2018 Manual Updates

December 2018
November 2018
October 2018
September 2018
August 2018
July 2018
June 2018
May 2018
April 2018
March 2018
February 2018
January 2018

Updates made during the current calendar year are included below. For updates prior to 2018, click on the subtopic corresponding to the year of interest. If you need to reference an archived manual section for a retired form, please refer to the Retired Forms Manuals webpage.

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December 2018

Date	Manual Section	Add/Remove/Modify	Description
12/21/2018	2116: PCD Post-HCT	Remove	Removed the following blue note box instruction (struck out below) for questions 30 and 126 regarding Flow Cytometry reporting for Myeloma. These assessments can now be reported in the same way as all other disease assessments. An exception of the note above applies to multiple myeloma If the flow cytometry assessment has < 5% malignant plasma cells, this result should not be reported because the result is not reliable; if no other cytogenetic or FISH assessments were performed, report “no.” However, if the flow cytometry assessment found ≥ 5% malignant plasma cells, this should be reported as evidence of disease.
12/21/2018	2450: Post-TED	Remove	Removed the following blue note box instruction (struck out below) above question 82 regarding Flow Cytometry reporting for Lymphoma and Myeloma. These assessments can now be reported in the same way as all other disease assessments. Myeloma and Lymphoma Flow cytometry assessments performed to detect myeloma or lymphoma should not be reported if negative (< 5% malignant cells detected). If flow cytometry was performed to detect myeloma or lymphoma and showed less than 5% malignant cells, report “not applicable” for question 82 and go to question 85.
12/13/2018	Toxicities	Modify	Added clarification on how hypogammaglobulinemia is documented: Report the date (YYYY-MM-DD) in question 126 when the hypogammaglobulinemia was documented by either a physician/health care provider or determined by lab results.
12/3/18	Multiple Myleoma Response Criteria	Modify	Separated the blue note box regarding urine studies to better reflect requirements needed for sCR and CR versus requirements needed for nCR, VGPR, and PR.
12/3/18	Amyloidosis Response Criteria	Add	Added further clarification for the Renal Response criteria (indicated in red below): ≥ 50% decrease of at least 0.5 g/day (500mg/24hr) in 24-hour urine protein of > 0.5 g/day (500mg/24hr) pre-treatment and Creatinine clearance must not have worsened by ≥ 25% over baseline
12/3/18	2400: Pre-TED	Modify	Updated link in the 2400 Pre-TED to reflect current reporting instructions for autologous transplants.

November 2018

Date	Manual Section	Add/Remove/Modify	Description
11/20/18	2400: Pre-TED	Add	Added the following text (in red below) for Question 5: Enter the ZIP code in which the recipient resides. Only five digits are required; however, if the ZIP+4 (nine digit) code is available, please report it in this field.
11/20/18	Multiple Myleoma Response Criteria	Add	Added the following (in red) to the Near Complete Remission (nCR) response criteria: < 5% plasma cells in bone marrow (confirmation with repeat bone marrow biopsy not needed).
11/20/2018	LYM Response Criteria	Modify	Modified the response criteria to show the metabolic response criteria first and then the radiographic response criteria for ease of use.
11/20/2018	4100: Cellular Therapy Essential Data Follow-Up	Modify	Added further clarification for various portions of this manual to provide better instruction on new sections of revision 4 of the Form 4100.
11/19/2018	4100: Cellular Therapy Essential Data Follow-Up	Modify	Added the following reporting instruction for question 76: This rapid cytokine release into the circulation results in fever (must be ≥100.4F or ≥38C), nausea, chills, hypotension, tachycardia, asthenia, headache, rash, sore throat, respiratory failure or death.
11/19/2018	4100: Cellular Therapy Essential Data Follow-Up	Modify	Added the following reporting instruction for questions 81-96: Symptoms of CRS: p(. Fevers (≥100.4F or ≥38C): A disorder characterized by elevation of the body’s temperature above the upper limit of normal. Do not report fever less if than 100.4F or 38C in this field. Fever less than 100.4F or 38C does not qualify as a symptom of CRS.

October 2018

Date	Manual Section	Add/Remove/Modify	Description
10/18/18	2018: LYM Pre-Infusion	Modify	For questions 231-232, a typographical error in the form was identified. These questions are intended to capture any extranodal involvement of a recipient’s Lymphoma. This section of the manual has been updated to reflect these changes.
10/18/18	2100: Post-HCT Follow-Up Data	Add	Added the following reporting instruction for Questions 486-487: Please indicate “no” if the patient received endotracheal intubation or mechanical ventilation during surgery.
10/17/18	2011: ALL Pre-Infusion Data	Modify	Modified (red text was added, struck out text was deleted) the instructional text for questions 37-38: Treatments vary based on protocol. A treatment may consist of a single drug or a combination of drugs. Additionally, the drugs may be administered on one day, over consecutive days, or continuously. If chemotherapy drugs were administered as part of the line of therapy, select the box for ‘chemotherapy’. You do not need to specify each drug. Select all chemotherapy drugs administered as part of the line of therapy being reported. If the recipient received a systemic therapy which is not listed, select “Other systemic therapy” and specify the treatment in question 38. Report the generic name of the agent, not the name brand.

September 2018

Date	Manual Section	Add/Remove/Modify	Description
9/20/2018	2018: LYM Pre-Infusion	Add	Added the following instruction for reporting pre-HCT lines of therapy: If this is a subsequent infusion and the 2018 was completed for the previous infusion, lines of therapy do not need to be reported in duplication on the subsequent 2018. Please report from post previous infusion to time of preparative regimen (or infusion) for the current HCT or cellular therapy. If no 2018 was completed previously, all lines of therapy from original diagnosis to current preparative regimen (or infusion) will have to be completed.
9/20/2018	2118: LYM Post-Infusion Data	Modify	Changed the instruction for for reporting questions 88 and 89 by removing (strike through) and adding (red) text as indicated below. The center does not need to repeat all disease-specific assessments (biopsies, i.e., CT (radiographic) or PET scans, labs) each reporting period in order to complete current disease status data fields. Once a particular disease status is achieved, the center can continue reporting that disease status (based on labs / clinical assessments) until there is evidence of relapse / progression. If a disease-specific assessment did not occur during this time period, please report the date of any disease related assessment ( e.g. clinical assessments, labs, etc.) as the date assessed (Q88 or Q90) regardless of what the parent question states about the specific CT (radiographic) or PET criteria.
9/20/2018	2000: Recipient Baseline	Modify	Removed If the specific organism is not listed, use the “other, specify” code 209 – candida, 219 – apsergillus, or 259 – fungus and report the name of the organism in the space provided for question 59. Modified language to complete a Fungal Infection Form for all organisms. Removed the list of fungal organisms
9/20/2018	2400: Pre-TED	Add	Added in text that mid-level health care providers (NPs and PAs) can also assign performance scores
09/20/2018	2004: Infectious Disease Markers	Add	Added the following text to Q10-46: Infectious Disease Markers section: If testing is only performed on the harvested product and not on the peripheral blood sample, report those samples accordingly.

August 2018

Date	Manual Section	Add/Remove/Modify	Description
8/10/18	2450: Post-TED	Modify	Modified (added text in red and deleted text is struck-out) the instructions for reporting the “date assessed” for questions 80, 83, 87, 90, 96, and 96: If the best response is “not in complete remission,” report the date of the most recent testing performed during the reporting period and prior to relapse or progression treatment for relapsed, progressive, or persistent disease, if applicable. If no treatment for relapsed, progressive, or persistent disease was given, report the date of the most recent disease-specific testing performed within approximately 30 days of the follow-up date.
8/10/18	2014: MDS/MPN Pre-HCT	Added	Added an instructional blue box for question 123: Myelofibrosis that develops in patients with essential thrombocythemia (ET) or polycythemia vera (PV) is considered secondary myelofibrosis. The CIBMTR forms capture disease subtype using the WHO classification of myeloid neoplasms and acute leukemia. Secondary myelofibrosis is not included as a separate category per the WHO classification. Therefore, when reporting the disease subtype at the time of transplant for recipients with secondary myelofibrosis, report “Primary Myelofibrosis (PMF)” to accurately capture these cases on the CIBMTR Forms.
8/10/18	2402: Disease Classification	Modify	Modified (red text was added, struck out text was deleted) the instructional blue box for question 212: Myelofibrosis that develops in patients with essential thrombocythemia (ET) or polycythemia vera (PV) is considered secondary myelofibrosis. The CIBMTR forms capture disease subtype using the WHO classification of myeloid neoplasms and acute leukemia. Secondary myelofibrosis is not included as a separate category per the WHO classification. Therefore, when reporting the disease subtype at the time of transplant for recipients with secondary myelofibrosis, report “Primary Myelofibrosis (PMF)” to accurately capture these cases on the CIBMTR Forms. Myelofibrosis that develops in patients with essential thrombocythemia (ET) or polycythemia vera (PV) is considered secondary myelofibrosis. However, effective immediately, cases of post-essential thrombocythemia myelofibrosis (post-ET MF) or post-polycythemia vera myelofibrosis (post-PV MF) will now be reported as “Primary Myelofibrosis (PMF)” at the time of HCT. In order to capture accurate data, the secondary MF cases need to be lumped in with the PMF cases, since treatment for post-ET MF and post-PV MF is the same as PMF.
8/10/18	2010: AML Pre-Infusion	Add	Added the following instruction for questions 72 – 74: If a differential was performed and there were no blasts present in the peripheral blood, the laboratory report may not display a column for blasts. In this case, it can be assumed that no blasts were present and “0” can be reported on the form.
8/10/18	2450: Post-TED	Remove	Removed the following instruction from questions 157 and 231: Reporting the administration of a cellular therapy / donor cellular infusion in question 231 will generate additional cellular therapy forms which are used to capture important details regarding the infusion(s).
8/10/18	2018: LYM Pre-Infusion	Add	Added instruction for question 217: If the recipient had palpable disease on a physical exam, those results can be reported in the CT (radiographic) criteria.
8/9/18	2402: Disease Classification	Add	Added instruction for question 281-282: If the PET scan result is only documented as an ‘X’, report this as “Unknown” for question 281.

July 2018

Date	Manual Section	Add/Remove/Modify	Description
7/25/18	2100: Post-HCT Follow-Up Data	Modify	Version 4 of the 2100: Post-HCT Follow-Up Data Form (Form 2100) (formerly 100 Day Post-HSCT Data Form) section of the Forms Instructions Manual released. Version 4 corresponds to revision 5 of the Form 2100.
7/25/18	2540: Tepadina Supplemental Data Collection	Add	Version 1 of the 2540: Tepadina Supplemental Data Collection section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2540.

June 2018

Date	Manual Section	Add/Remove/Modify	Description
6/25/18	2150: Viral Infections	Modify	Added (in red below) and removed (struck out below) text from the instructions for reporting infection status at the time of evaluation for this reporting period (question 77): If the status of the infection is not documented in the HCT / cellular therapy physician’s note summarizing their last evaluation performed during the reporting period, obtain documentation from the provider indicating which option to report. For reporting purposes, centers should indicate “Ongoing” if the infection is still present, but cannot be considered improved or resolved. Ongoing: Infection is still present, but cannot be considered improved or resolved Improved: Still on treatment, but responding to treatment and no longer showing signs / symptoms of infection Resolved: Treatment completed Unknown
6/25/18	2150: Viral Infections	Modify	Added (in red below) further instruction on reporting therapy (question 51): Report “Yes” if the recipient received any antiviral medication between seven days prior to the date of diagnosis (refer to question two) and the date of contact for the reporting period (refer to the date of contact reported on the corresponding Post-HCT Follow-Up Data Form). Report all therapy received regardless of the infection being treated.
6/22/18	4100 Cellular Therapy Essential Data Follow-Up	Modify	Added (in red below) further instruction on reporting symptoms in a reporting period: If “yes” is reported for a symptom, report the date of diagnosis (YYYY-MM-DD) of each symptom and indicate if the symptom was explained entirely by non-CRS causes (e.g. infection, therapy). If a symptom occurs multiple times within the same reporting period (e.g. fever), report the first occurrence.
6/1/18	2400: Pre-TED	Modify	Re-formatted the reporting instructions for pre-HCT CMV-antibody results (question 94) and included the following additional consideration (in red below): Documented history of “reactive” CMV: In cases where a recipient has a documented history of a “reactive” CMV test and does not have a history of IVIG or blood transfusions from a CMV positive donor, “reactive” should be reported for the CMV status even if the CMV test is repeated during the pre-HCT work-up phase and is “non-reactive”.
6/1/18	AML Response Criteria	Add	Added (in red below) further instruction on reporting the CRi response criteria: Transfusion independent (Please note, if the physician documents transfusion dependence related to treatment and not the patient’s underlying AML, CRi can be reported)
6/1/18	ALL Response Criteria	Add	Added (in red below) further instruction on reporting the CRi response criteria: Transfusion independent (Please note, if the physician documents transfusion dependence related to treatment and not the patient’s underlying ALL, CRi can be reported)

May 2018

Date	Manual Section	Add/Remove/Modify	Description
5/21/18	2400: Pre-TED	Modify	Added (in red below) and removed (struck out below) text from the instructions for reporting comorbidities (questions 98-134). Arrhythmia: Any history of any type of arrhythmia that has necessitated the delivery of a specific antiarrhythmic agent. Examples include, but are not limited to, atrial fibrillation or flutter, sick sinus syndrome, or and ventricular arrhythmias requiring treatment. Cardiac: Any history of coronary artery disease (one or more vessel coronary artery stenosis requiring medical treatment, stent, or bypass graft), congestive heart failure, myocardial infarction, and / or ejection fraction ≤ 50% (shortening fraction < 26 for pediatric recipients)% on the most recent test. Cerebrovascular disease: Any history of transient ischemic attack, subarachnoid hemorrhage, and / or cerebrovascular accident cerebral thrombosis embolism, or hemorrhage. Diabetes: Diabetes or steroid-induced hyperglycemia requiring continuous treatment with insulin or oral hypoglycemics in the last 4 weeks. but not diet alone Heart valve disease: Moderate or severe valve stenosis or insufficiency (mitral, aortic, tricuspid, or pulmonary) as determined by echocardiogram, prosthetic mitral or aortic valve, and / or symptomatic mitral valve prolapse. Except asymptomatic mitral prolapse. Psychiatric disturbance: The presence of any mood, anxiety, or other psychiatric disorder requiring continuous treatment during the last four weeks. Examples include, but are not limited to, depression, anxiety, bipolar disorder, or and schizophrenia requiring psychiatric treatment in the last 4 weeks. Pulmonary (moderate): Corrected diffusion capacity of carbon monoxide (e.g., DLCOc, DLCOcorr, DLCO) and/or FEV1 66-80% or dyspnea on slight activity at transplant. Use the Dinakara equation below to determine the DLCOc if only an uncorrected value is provided. For recipients assessed by a postbronchodilator test, only the prebronchodilator FEV1 values are considered for evaluation of pulmonary comorbidity. Dinakara Equation: DLCOc = {uncorrected DLCO} / [0.06965 x {hemoglobin g/dL}] Pulmonary (severe): Corrected diffusion capacity of carbon monoxide (e.g., DLCOc, DLCOcorr, DLCO) and/or FEV1 ≤ 65% or dyspnea at rest or requiring oxygen at transplant. Use the Dinakara equation above to determine the DLCOc if only an uncorrected value is provided. or recipients assessed by a postbronchodilator test, only the prebronchodilator FEV1 values are considered for evaluation of pulmonary comorbidity. Renal (moderate/severe): Serum creatinine > 2 mg/dL or > 176.8 177 μmol/L, or on dialysis at transplant, or prior renal transplantation. See note in question 97.
5/10/18	2100: Post-HCT Follow-Up	Add	Added Fecal Microbiota Transplant note box to acute (questions 185-233) and chronic (questions 328-399) GVHD treatment instructions.
5/10/18	LYM Response Criteria	Add	Added “Relapsed Disease” to “Progressive Disease” criteria and included clarification on when to report these disease status.
5/7/18	2553: VOD/SOS	Add	Added an example on how to report the planned total daily dose for Defibrotide
5/7/18	2400: Pre-TED	Modify	Modified language on how to report Drugs After Transplant, replaced “day 0” with “transplant” to clarify how to report drugs planned for day 0
5/7/18	2400: Pre-TED	Add	Added note box to capture all comorbidities including those that are considered complications of the primary disease for transplant and provided examples
5/1/18	2150: Viral Infections	Add	Version 1 of the 2150: Viral Infections section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2150.
5/1/18	2046: Fungal Infection Pre-Infusion Data	Modify	Version 2 of the 2046: Fungal Infection Pre-Infusion Data section of the Forms Instructions Manual released. Version 2 corresponds to revision 5 of the Form 2046.
5/1/18	2146: Fungal Infection Post-Infusion Data	Modify	Version 2 of the 2146: Fungal Infection Post-Infusion Data section of the Forms Instructions Manual released. Version 2 corresponds to revision 4 of the Form 2146.
5/1/18	2565: Sanofi Mozobil Supplemental Data Collection	Add	Version 1 of the 2565: Sanofi Mozobil Supplemental Data Collection section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 2565.

April 2018

Date	Manual Section	Add/Remove/Modify	Description
4/30/18	2450: Post-TED	Add	Added the following instruction for question 34. Please note, questions 35 and 36 must still be answered if question 34 is reported as “unknown.”
4/30/18	2450: Post-TED	Modify	Updated language on how to report the “Date of most recent disease assessment” for questions 237-238: current disease status.
4/20/18	Appendix M: Critical Data Fields	Modify	New version of Appendix M: Critical Data Fields of the Forms Instructions Manual released. Note, prior versions of this appendix were referred to as Appendix Y: Critical Data Fields.
4/20/18	4003: Cellular Therapy Product	Add	Added Cryopreservation as a Manipulation note box to the instructions for questions 31-32.
4/16/18	2000: Recipient Baseline	Add	Added Fungal Infection Diagnosis Reporting Scenario to the instructions for question 57.
4/10/18	2402: Disease Classification	Modify	Updated the Common Disease Transformation Table included in the instructions for questions 1 and 2. The CLL section of the form should not be completed for a Richter’s Transformation as of Revision 3 of the Form 2402.
4/10/18	4006: Cellular Therapy Infusion	Add	Added in additional clarification regarding total cell counts administered, what constitutes unselected lymphocytes, and T-helper cells (Q17-24).
4/9/18	2402: Disease Classification	Modify	Modified the following instruction for question 317: Enter the date of the most recent assessment of disease status prior to the start of the preparative regimen. Report the date the blood/urine was collected for the laboratory evaluations (e.g., SPEP/UPEP, serum/urine immunofixation) or report the date the bone marrow was collected for pathological evaluation. A PET scan Date of radiographic study (PET, MRI, CT) may be used if the same a previous PET scan radiographic study had previously been obtained and only in limited circumstances (e.g., plasmacytomas, lytic lesions).

March 2018

Date	Manual Section	Add/Remove/Modify	Description
4/23/18	2018: LYM Pre-Infusion Data	Modify	Corrected errors in the instruction manual by adding (in red below) and removing (struck out below) text to the instructions for questions 269-272, 273-276, and 277-280. Indicate the result of [method] testing performed at the last evaluation prior to the start of the preparative regimen / infusion. If testing was “Positive,” or “Negative,” report the sample source in questions [question numbers]… If all [method] testing was negative or testing was not done at the last evaluation prior to the start of the preparative regimen, report “Negative” or “Not done” respectively…
4/20/18	4003: Cellular Therapy Product	Add	Added Cryopreservation as a Manipulation note box to the instructions for questions 31-32.
3/27/18	2100: Post-HCT Follow-Up	Add	Added HHV-6 to Definitions for Same Infection Table included in the instructions for questions 428-436.
3/22/18	2402: Disease Classification	Add	Added MDS/MPN note box below the instructions for question 256 regarding recipients who only received supportive care prior to transplant.
3/19/18	Multiple Myeloma Response Criteria	Add	Added in Progressive Disease (PD) response criteria (red) with regards to plasmacytomas: Definite development of new bone lesions or soft tissue plasmacytomas, or definite increase in the size of any existing bone lesions or soft tissue plasmacytomas (≥ 50%increase from nadir in size of >1 lesion, or a ≥ 50%increase in the longest diameter of a previous lesion >1 cm in short axis).
3/19/18	2556: Myelofibrosis CMS Study Pre-HCT Data	Add	Added in instruction (red) on how to report previous JAK1 and JAK2 inhibitor therapy as indicated below: Indicate “yes” if the recipient received JAK1 or JAK2 therapy prior to the current HCT (not including therapy given for past HCTs that have previously been reported) and continue with question 19. If “no,” continue with question 34. This modification was also made to the blue note box above Q18.
3/19/18	4000: Cellular Therapy Essential Data Pre-Infusion	Add	Added in clarification regarding what constitutes a course of cellular therapy.
3/19/18	4000: Cellular Therapy Essential Data Pre-Infusion	Remove	Removed the following example regarding how to specify the total number of products for Q29: Example 4. A recipient receives a post-HCT donor cellular infusion. Based on the disease status after the infusion, a second donor cellular infusion is planned to be given if the recipient does not respond. This is considered two different courses of cellular therapy and each product should be reported separately.
3/19/18	2116: PCD Post-HCT	Add	Added Current Disease Status note box above the instructions for Q137.
3/19/18	2118: LYM Post-Infusion Data	Modify	Change the instruction for question 89 by removing (strike through) and adding (red) text as indicated below. The current disease status should reflect the most recent disease evaluations performed during the reporting period. Report “Not assessed” and submit the form if the recipient’s primary disease is a non-PET avid lymphoma or a PET scan was not performed during the reporting period since the infusion.
3/19/18	Comprehensive Disease Specific Manuals	Add	Added the following instruction for applicable post-infusion disease-specific forms where current disease status is asked (2110, 2111, 2112, 2113, 2114, 2115, 2116, 2118, 2119). The center does not need to repeat all disease-specific assessments (biopsies, scans, labs) each reporting period in order to complete current disease status data fields. Once a particular disease status is achieved, the center can continue reporting that disease status (based on labs / clinical assessments) until there is evidence of relapse / progression.
3/19/18	2450: Post-TED	Add	Added the following instruction for question 235. The center does not need to repeat all disease-specific assessments (biopsies, scans, labs) each reporting period in order to complete current disease status data fields. Once a particular disease status is achieved, the center can continue reporting that disease status (based on labs / clinical assessments) until there is evidence of relapse / progression.
3/8/18	4100: Cellular Therapy Essential Data Follow-Up	Add	Added GVHD note box at the beginning of the GVHD section.
3/8/18	4006: Cellular Therapy Infusion	Add	Added Product Identification note box above question 1.
3/5/18	2450: Post-TED	Modify	Updated language on what to capture as a molecular assessment for questions 75-97.
3/5/18	Cellular Therapy Manuals	Add	Added information regarding what cellular therapies to report and when.
3/2/18	ALL Response Criteria	Remove	Removed the following bullet from the CRi criteria. No blasts with Auer rods
3/1/18	2000: Recipient Baseline	Add	Added Infusion Without a Preparative Regimen note box at the beginning of Q6-14: Clinical Status of Recipient Prior to the Preparative Regimen (Conditioning), Q15-38: Organ Function Prior to the Preparative Regimen (Conditioning), and Q39-54: Hematologic Findings Prior to the Preparative Regimen (Conditioning).

February 2018

Date	Manual Section	Add/Remove/Modify	Description
2/28/18	2402: Disease Classification	Add	Added the following instruction for question 283. When a transformation has occurred (e.g., follicular lymphoma (FL) transformed to DLBCL), count the response number (CR1, REL2, etc.) beginning with the transformed lymphoma (in this case the DLBCL). Do not include the responses to the lymphoma sub-type prior to the transformation.
2/27/18	2402: Disease Classification	Add	Added instruction for questions 281-282. If multiple scores are documented, report the highest.
2/22/18	2110: AML Post-Infusion Data	Modify	Added (in red) and removed (struck out) text from instructions for questions 51-52. If any testing for molecular markers occurred detected the recipient’s primary disease during the reporting period, report “Yes” for question 51 and report the date the sample was collected in question 52. If molecular marker testing did not detect disease at any time during the reporting period, report “No” for question 51 and go to question 63. If molecular marker testing was not performed during the reporting period, report “No Unknown” go to question 63.
2/22/18	2110: AML Post-Infusion Data	Modify	Added (in red) and removed (struck out) text from the beginning of section Q51-103: Disease Detection Since Date of Last Report If testing by a particular method for molecular or cytogenetic markers / abnormalities was not done during the reporting period or it is not known whether testing was performed, report “Unknown” for that method those methods (question 51 and 70). If testing by flow cytometry, clinical / hematologic assessment, or other assessment was not done during the reporting period or it is not known whether testing was performed, report “No” for those methods (questions 63, 80, and 87).
2/22/18	2110: AML Post-Infusion Data	Add	Added text (in red) to the Questions 51-103 warning box. For questions 51, 63, 70, 80, and 87, report “No” or “Unknown” (see instructions below) if the recipient did not relapse, have persistent or minimal residual disease even if testing was performed.
2/22/18	2111: ALL Post-Infusion Data	Modify	Added (in red) and removed (struck out) text from instructions for questions 48-49. If any testing for molecular markers occurred detected the recipient’s primary disease during the reporting period, report “Yes” for question 48 and report the date the sample was collected in question 49. If molecular marker testing did not detect disease at any time during the reporting period, report “No” for question 48 and go to question 49. If molecular marker testing was not performed during the reporting period, report “No Unknown” go to question 53.
2/22/18	2111: ALL Post-Infusion Data	Modify	Added (in red) and removed (struck out) text from the beginning of section Q48-94: Disease Detection Since Date of Last Report If testing by a particular method for molecular or cytogenetic markers / abnormalities was not done during the reporting period or it is not known whether testing was performed, report “Unknown” for that method those methods (question 48 and 61). If testing by flow cytometry, clinical / hematologic assessment, or other assessment was not done during the reporting period or it is not known whether testing was performed, report “No” for those methods (questions 54, 71, and 78).
2/22/18	2111: ALL Post-Infusion Data	Add	Added text (in red) to the Questions 48-94 warning box. For questions 48, 54, 61, and 78, report “No” or “Unknown” (see instructions below) if the recipient did not relapse, have persistent or minimal residual disease even if testing was performed.
2/20/18	Appendix C: Cytogenetic Assessments	Add	Added table below figure 3 to explain karyotype findings.
2/20/18	2100: Post-HCT Follow-Up	Add	Added text (in red below) to the instructions for question 304. This instruction was / is available on the form. Report the date of maximum chronic GVHD involvement since the date of last report, based on clinical grade.
2/20/18	2100: Post-HCT Follow-Up	Add	Added the following instruction for question 303. This instruction was / is available on the form. Report the extent of chronic GVHD since the date of last report.
2/20/18	2100: Post-HCT Follow-Up	Add	Added text (in red below) to the instructions for question 302. This instruction was / is available on the form. Report the maximum chronic GVHD involvement since the date of last report, based on clinical grade, as documented by the recipient’s primary care provider.
2/15/18	4000: Cellular Therapy Essential Data Pre-Infusion	Modify	Removed text (struck out below) and added text (in red below) to the instructions for question 49. If the indication for cellular therapy is relapsed, persistent or progressive disease (post-HCT), the indication should be the primary disease for which the cellular therapy is being given. If the recipient is receiving post-HCT cellular therapy (e.g. DCI/DLI) for relapsed, persistent, or progressive disease, the indication should be recorded as “malignant hematologic disorders” and complete a new F2402 for the disease that has relapsed/persisted/progressed.
2/14/18	2402: Disease Classification	Remove	Removed incorrect instruction (struck out below) from question 271. If the histology reported at infusion (question 268) is a transformation from CLL, indicate “Yes,” and go to question 272. Also, complete the disease classification questions for CLL.
2/13/18	2100: Post-HCT Follow-Up	Add	Added Liver Toxicity Prophylaxis note box above the instructions for question 490.
2/13/18	4000: Cellular Therapy Essential Data Pre-Infusion	Remove	Removed the instruction below from section Q68-93: Disease Assessment at Last Evaluation Prior to Cellular Therapy. Specify the method(s) of disease detection below. For each method used, if the result was positive report the first date the disease was detected; if the result was negative report the last date the method was used prior to cellular therapy.
2/13/18	2116: PCD Post-HCT	Add	Added Daratumumab note box to the instructions for questions 69-90.
2/13/18	2016: PCD Pre-HCT	Add	Added Daratumumab note box to the instructions for questions 196-222.
2/12/18	Appendix C: Cytogenetic Assessments	Add	Added the following description of constitutional abnormalities. Karyotyping may also detect constitutional abnormalities. These are abnormalities present since birth. Examples include, but are not limited to, trisomy 21 and Klinefelter’s syndrome. It is not necessary to report constitutional abnormalities when reporting karyotyping results.
2/9/18	Appendix C: Cytogenetic Assessments	Modify	Version 2 of Appendix C: Cytogenetic Assessments of the Forms Instruction Manual released.
2/7/18	2000: Recipient Baseline	Modify	Updated the list of fungal species that require Form 2046 to be completed. Items added are in red. Items removed are struck out. This list is provided in the instructions for questions 58-59. Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger, Other Aspergillus specify , Aspergillus NOS, Aspergillus terreus, Aspergillus ustus, Blastomyces (dermatitidis), Candida albicans, Candida non-albicans, Cryptococcus gattii, Cryptococcus neoformans, Fusarium (all species), Histoplasma (capsulatum), Mucorales (all species), Mucormycosis, Rhizopus (all species),Scedosporium (all species), Zygomycetes NOS, Suspected fungal infection
2/2/18	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Modify	Removed text (struck out below) from the instructions for question 272.

January 2018

Date	Manual Section	Add/Remove/Modify	Description
1/30/18	LYM Response Criteria	Add	Version 2 of the Lymphoma Response Criteria section of the Forms Instruction Manual released. Version 2 corresponds to revision 4 of the LYM Pre- and Post-Infusion Forms (Forms 2018 / 2118).
1/30/18	2018: LYM Pre-Infusion Data	Modify	Version 3 of the 2018: LYM Pre-Infusion Data section of the Forms Instruction Manual released. Version 3 corresponds to revision 4 of the Form 2018.
1/30/18	2118: LYM Post-Infusion Data	Modify	Version 3 of the 2118: LYM Post-Infusion Data section of the Forms Instruction Manual released. Version 3 corresponds to revision 4 of the Form 2118.
1/30/18	3500: Subsequent Neoplasms	Add	Version 1 of the 3500: Subsequent Neoplasms section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 3500.
1/30/18	4100: Cellular Therapy Essential Data Follow-Up	Modify	Version 3 of the 4100: Cell Therapy Essential Data Follow-Up section of the Forms Instruction Manual released. Version 3 corresponds to revision 3 of the Form 4100.
1/30/18	4003: Cellular Therapy Product	Add	Version 1 of the 4003: Cell Therapy Product section of the Forms Instruction Manual released. Version 1 corresponds to revision 1 of the Form 4003.
1/30/18	4006: Cellular Therapy Infusion	Modify	Version 3 of the 4006: Cell Therapy Infusion section of the Forms Instruction Manual released. Version 3 corresponds to revision 3 of the Form 4006.
1/30/18	2402: Disease Classification	Modify	Version 3 of the 2402: Disease Classification section of the Forms Instruction Manual released. Version 3 corresponds to revision 3 of the Form 2402.
1/24/18	2116: PCD Post-HCT	Add	Added Not Applicable Amyloidosis note box to the instructions for question 135.
1/24/18	2116: PCD Post-HCT	Remove	Removed text (struck out below) from the instructions for question 96. If the recipient had amyloidosis or POEMS syndrome, but no evidence of myeloma, select “Not Applicable (Amyloidosis with no evidence of myeloma) .”
1/24/18	2116: PCD Post-HCT	Add	Added Amyloidosis note box to the instructions for questions 96.
1/23/18	2402: Disease Classification	Remove	Removed text (struck out below) from the instructions for question 307. If the primary disease is Amyloidosis or POEMS, report “Not applicable” and go to the signature line.
1/23/18	2402: Disease Classification	Add	Added Amyloidosis note box to the instructions for question 307.
1/23/18	2450: Post-TED	Add	Added Amyloidosis note box above the instructions for question 75.
1/23/18	2016: PCD Pre-HCT	Remove	Removed text (struck out below) from the instructions for questions 229 and 363. If the recipient had amyloidosis or POEMS syndrome, but no evidence of myeloma, select “Not Applicable (POEMS or Amyloidosis with no evidence of myeloma) ” and continue with …
1/23/18	2016: PCD Pre-HCT	Add	Added Amyloidosis note box to the instructions for questions 229 and 363.
1/23/18	2400: Pre-TED	Add	Added text (in red below) to the description of HLA-mismatched relative provided in the instructions for question 40. Includes: Siblings who are not HLA-identical and all other blood-related relatives who have at least one HLA mismatch (e.g., parents, aunts, uncles, children, cousins, half-siblings). This includes haploidentical donors.
1/23/18	2400: Pre-TED	Add	Added Haploidentical Donors note box to the instructions for question 40.
1/23/18	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Modify	Added text (highlighted red below) to the instructions for question 272 to clarify hospitalization scenarios. Indicate “Yes” if the donor was hospitalized for complications during or after the collection for any reason. Indicate “No” if the donor was not hospitalized as an inpatient or if the donor was admitted to an observation unit and discharged in less than 24 hours.
1/23/18	4100: Cellular Therapy Essential Data Follow-Up	Add	Added HCT and CT note box above question 44.

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