Q67 – 96: Hematopoietic Cellular Transplant (HCT) and Cellular Therapy

Question 67: Is a subsequent HCT planned as part of the overall treatment protocol? (not as a reaction to post-HCT disease assessment) (For autologous HCTs only)

If, at the time of the current HCT, a second (tandem transplant) or subsequent HCT is planned according to the protocol, check Yes even if the recipient does not receive the planned subsequent HCT. The word “planned” should not be interpreted as: if the recipient relapses, then the “plan” is to perform a subsequent HCT.

Question 68: Specify subsequent HCT planned

Report the planned type of the subsequent HCT.

!Subsequent Infusions for Poor Graft Response
If the allogeneic recipient receives an infusion due to poor graft response, count the infusion as a subsequent HCT. The exception to this is “autologous rescue.” Autologous rescues should not be counted as a separate HCT and the data collection forms will not start over (i.e., the forms will continue from the previous HCT).

Question 69: Has the recipient ever had a prior HCT?

Specify if the recipient ever had a prior HCT. Include all HCTs in the recipient’s history, even if the transplants were performed at different centers. The intent is to capture the full picture of the recipient’s treatment / transplant history.

Question 70: Specify the number of prior HCTs

Enter the number of prior HCTs for the recipient. An HCT event is defined as an infusion of mobilized peripheral blood stem cells (PBSC), bone marrow, or cord blood. For more information on how to distinguish infusion types (i.e., HCT versus DLI), see Appendix D: How to Distinguish Infusion Types.

Reporting Scenarios
For recipients who have received a previous HCT (prior to the HCT for which this form is being completed), the following are examples of how to calculate the number of prior HCTs.

• Example 1: A recipient was previously transplanted under a protocol that included an infusion of cells over multiple days: day 0, day +1 and day +2. This series of infusions is considered one HCT event (as opposed to three HCT events) and should be counted as HCT Event #1.
• Example 2: A recipient previously received an allogeneic HCT (HCT Event #1). Then, due to delayed neutrophil recovery, the recipient received additional cryopreserved allogeneic mobilized PBSC from the original donor, without a preparative regimen (i.e., “boost” – HCT Event #2). One prior HCT should be reported.
• Example 3: A recipient previously received an autologous HCT (HCT Event #1). Then due to delayed neutrophil recovery, the recipient received additional cryopreserved autologous cells without a preparative regimen (i.e., “boost” which is not counted as an HCT event because the intent of the autologous infusion is to treat the graft failure). The boost is successful, but a few years later the recipient develops a new malignancy. The recipient is scheduled to receive a subsequent autologous HCT with preparative regimen (HCT Event #2). One prior HCT should be reported.
  

*Prior HCTs reported to CIBMTR
If Unknown is selected for Were all prior HCTs reported to CIBMTR, Date of prior HCT, Was the prior HCT performed at a different institution, Specify the institution that performed the last HCT, and What was the HPC source for the prior HCT questions can still be answered to report information regarding prior HCTs; however, these questions are not required to be completed.

Question 71: Were all prior HCTs reported to CIBMTR?

Specify if all prior HCTs were reported to CIBMTR. This should include any / all HCTs not performed at this center. If the recipient is a transfer recipient, reported past HCT dates can be found in the Recipient Information Grid in FormsNet3^SM.

Contact CIBMTR Center Support if there are questions.

*Reporting Prior HCTs
Complete the Date of prior HCT, Was the prior HCT performed at a different institution, Specify the institution that performed the last HCT, and What was the HPC source for the prior HCT questions to report all prior HCTs that have not yet been reported to CIBMTR by adding an additional instance in the FormsNet3^SM application.

Question 72: Date of prior HCT

Report the date (YYYY-MM-DD) of the prior HCT being reported in this instance. If the exact date is unknown and must be estimated, check the Date estimated box.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 73: Was the prior HCT performed at a different institution?

Indicate if the prior HCT being reported in this instance was performed at another institution.

Questions 74 – 75: Was the prior HCT performed at a CIBMTR Affiliated Network Center?

Specify if the prior HCT was performed at a CIBMTR Affiliated Network Center. If Yes, select the CIBMTR Center Number (CCN).

Question 76: Specify Non-CIBMTR Affiliated Network Center

Report the name, city, state, and country of the non-CIBMTR Affiliated Network Center where the recipient’s prior HCT was performed. These data are used to identify and link the recipient’s existence in the database and, if necessary, obtain data from the other institution where the previous infusion was administered.

Question 77: What was the donor source(s) for the prior HCT? (check all that apply)

Report the cell source(s) for the prior HCT being reported in this instance.

• Autologous: Cells collected from the recipient for his / her own use.
• Allogeneic, unrelated: An unrelated donor who shares no known ancestry with the recipients. Include adoptive parents / children or stepparents / children.
• Allogeneic, related: A related donor who is a blood-related relative. This includes monozygotic (identical twins), non-monozygotic (dizygotic, fraternal, non-identical) twins, siblings, parents, aunts, uncles, children, cousins, half-sibling, etc.
  

Questions 78 – 79: Specify product type (check all that apply)

Specify the product type infused for the prior HCT.

If Other product type is selected, specify the other product infused.

Questions 80 – 84: Reason for current HCT

Indicate the reason for the current HCT (check only one). If this was a subsequent transplant, verify that this answer is consistent with the reason for the subsequent transplant reported on the previous series of report forms.

• Graft failure: Additional stem cells are required because the ANC did not recover following HCT (primary graft failure), or hematopoietic recovery indefinitely declined after the initial hematopoietic recovery or hematopoietic recovery (secondary graft failure)
  • Autologous infusion: If autologous cells are infused for this reason, this is considered an autologous rescue. Reporting will continue under the prior HCT date, and a new Pre-TED form is not required.
  • Allogeneic infusion: If allogeneic cells are infused, regardless of whether a new allogeneic donor or a prior allogeneic donor is used, this is considered a subsequent HCT. A new Pre-TED is required, and a new set of follow-up forms will come due, as applicable.
• Poor graft function / insufficient donor chimerism: Additional stem cells are required because hematopoietic recovery was deemed insufficient or too slow for survival following previous high-dose therapy and HCT.
  • Autologous infusion: If autologous cells are infused for this reason, this is considered an autologous rescue. Reporting will continue under the prior HCT date, and a new Pre-TED form is not required.
  • Allogeneic infusion using a prior allogeneic donor: If allogeneic cells from a prior donor are infused, this is considered an allogeneic boost. Reporting will continue under the prior HCT date, and the Donor Cellular Infusion (2199) Form is required.
  • Allogeneic infusion using a new allogeneic donor: If allogeneic cells are infused using a new allogeneic donor, this is considered a subsequent HCT. A new Pre-TED is required, and a new set of follow-up forms will come due, as applicable.
  • In the case of a stable, mixed donor chimerism, the infusion of additional cells (usually lymphocytes and not mobilized stem cells) is typically classified as a DCI. Verify with the transplant physician that the cells given should be reported as a subsequent transplant and that stable, mixed chimerism is the reason for the transplant. However, in the case of declining chimerism – when the percentage of donor cells is sequentially decreasing on several studies, indicating possible impending graft failure – additional stem cells are required. Usually, the donor chimerism has fallen below 30-50%.
• Persistent primary disease: Additional stem cells are required because of the persistent presence of disease pre- and post-infusion (i.e., clinical / hematologic complete remission was never achieved following the previous infusion, clinical / hematologic complete remission was achieved but disease persisted by other methods of assessments (molecular, flow cytometry, cytogenetics)).
• Recurrent primary disease: Additional stem cells are required because of relapse of the primary disease by any method of assessment (i.e., clinical / hematologic complete remission was achieved pre- or post-infusion, but the disease relapsed following the previous infusion, clinical / hematologic and molecular complete remission was achieved pre- or post-infusion, but the disease relapsed by molecular assessments following the previous infusion). If selected, report the relapse date. If multiple relapses have occurred since the previous infusion, report the date of the most recent relapse.
• Planned subsequent HCT, per protocol: Additional stem cells are given as defined by the protocol for a subsequent transplant / infusion. This infusion is not based upon recovery, disease status, or any other assessment.
• New malignancy (including PTLD and EBV lymphoma): Additional stem cells are required because the recipient developed a new malignancy. This does not include a transformation or progression of the original malignancy for which the recipient was transplanted (i.e., MDS progressed to AML). If selected, report the diagnosis date of the new malignancy.
• Other: If additional stem cells are given for a reason other than the options listed, specify the reason.
  

Question 85: Has the recipient ever had a prior cellular therapy? (do not include DLIs)

Specify if the recipient ever had a prior cellular therapy, excluding DLIs. Include all cellular therapy infusions, except DLIs, in the recipient’s history, even if the infusions were not performed at the same center. The intent is to capture the full picture of the recipient’s treatment history.

*Prior cellular therapy reported to CIBMTR
If Unknown is selected for Were all prior cellular therapies reported to CIBMTR, Date of the prior cellular therapy, Was the cellular therapy performed at a different institution, Specify the institution that performed the cellular therapy, and Specify the source(s) for the prior cellular therapy questions can be answered to report information regarding prior cellular therapies; however, these questions are not required to be completed.

Question 86: Were all prior cellular therapies reported to CIBMTR?

Indicate if all prior cellular therapies were reported to CIBMTR. This should include all cellular therapy infusions (except for DLIs) not performed at your center. If the recipient is a transfer recipient, reported past infusion dates can be found in the Recipient Information Grid in FormsNet3^SM.

Contact CIBMTR Customer Support if there are any questions.

*Reporting Multiple Prior Cellular Therapies
Complete the Date of the prior cellular therapy, Was the cellular therapy performed at a different institution, Specify the institution that performed the cellular therapy, and Specify the source(s) for the prior cellular therapy questions to report all prior cellular therapies that have not yet been reported to CIBMTR by adding an additional instance in the FormsNet3^SM application.

Question 87: Date of the prior cellular therapy

Report the date (YYYY-MM-DD) of the prior cellular therapy being reported in this instance.

For information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 88: Was the cellular therapy performed at a different institution?

Indicate if the prior cellular therapy being reported in this instance was performed at another institution.

Questions 89 – 90: Was the prior cellular therapy performed at a CIBMTR Affiliated Network Center?

Specify if the prior cellular therapy was performed at a CIBMTR Affiliated Network Center. If Yes, select the CIBMTR Center Number (CCN).

Question 91: Specify Non-CIBMTR Affiliated Network Center

Report the name, city, state, and country of the non-CIBMTR Affiliated Network Center where the recipient’s prior cellular therapy was performed. These data are used to identify and link the recipient’s existence in the database and, if necessary, obtain data from the other institution where the previous infusion was administered.

Question 92: Specify the donor source(s) for the prior cellular therapy? (check all that apply)

Report the cell source(s) for the prior HCT being reported in this instance.

• Autologous: Cells collected from the recipient for his / her own use.
• Allogeneic, unrelated: An unrelated donor who shares no known ancestry with the recipients. Include adoptive parents / children or stepparents / children.
• Allogeneic, related: A related donor who is a blood-related relative. This includes monozygotic (identical twins), non-monozygotic (dizygotic, fraternal, non-identical) twins, siblings, parents, aunts, uncles, children, cousins, half-sibling, etc.
  

*Recipient Research Repository Consent and Prior Infusions
The recipient consent to the Research Repository question should only be answered for the recipient’s first allogeneic transplant. If the recipient has had prior autologous or cellular therapy infusions, and this infusion is the first allogeneic, override the error message. If the recipient has had prior allogeneic infusion(s), leave this question blank.

Question 93: Has the recipient signed an IRB / ethics committee (or similar body) – approved consent form to donate research blood samples to NMDP / CIBMTR? (For allogeneic HCTs only)

The Research Sample Repository contains blood samples from unrelated recipients and/or their adult volunteer donors or cord blood units. Related allogeneic recipients and/or donors will participate at selected transplant centers.

The primary objective of the Research Repository is to make blood samples available for research studies related to histocompatibility and hematopoietic cellular transplantation.

Studies in which these data may be used include

• Improving the understanding of tissue matching hematopoietic cellular donors and recipients.
• Determining and evaluating the factors that affect transplant outcomes.
• Studying the distribution of HLA tissue types in different populations (e.g., study tissue typing differences between different racial and ethnic populations to help develop methods to improve tissue matching between donors and recipients, including testing of rare HLA types).
  

Indicate if the recipient signed an IRB-approved consent form to donate research blood samples to NMDP / CIBMTR.

For subsequent allogeneic transplants, this question is disabled, and blood samples are not submitted as consent and blood sample collection is only required for the first allogeneic transplant.

Question 94: Date form was signed

Report the date the research sample consent form was signed by the recipient. Do not report the date that the witness or health care professional signed the consent form.

Questions 95 – 96: Did the recipient submit a research sample to the NMDP / CIBMTR repository? (Related donors only)

There are a select number of transplant centers participating in the Related Specimen Repository. If this center is one of the participating centers, and the recipient provided a research sample, select Yes and provide the recipient’s sample ID in Research sample recipient ID for the current infusion. The ID number is located on the bar code that is attached to the sample tube.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.