To access follow-up visit CRFs, click on the Enter Date box and enter the date of the study visit. Click Continue. If the date entered is a future date, a query will appear in the EDC.
This form will only appear in the EDC if the “Has the disease relapsed or progressed since last reported for the study” field on Follow-Up Assessments form (Day 28 – Day 365) is answered Yes.
For relapse or progression identified between visits (e.g., relapse identified between D56 and D100), please complete the following:
- In Veeva EDC, record the date relapse or progression of disease was first detected as the visit’s Event Date to trigger the visit forms. If this date falls outside of the visit’s window, a warning message will generate:
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- Click “Save” to confirm the date. This will result in a system query (example below). A comment can be added to indicate relapse occurred prior to the next visit:
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- Report the relapse / progression on the following CRF:
- Report relapse or progression of disease in relapse / progression specific fields on the Follow-Up Assessment CRF. Report further details on the Relapse / Progression and Research Sample Collection (Relapse) (if applicable) CRFs once the Follow-Up Assessment CRF is saved.
- Complete the Off Protocol CRF indicating either relapse / progression on or before Day 100 or relapse / progression after Day 100 (as appropriate) as the off protocol reason.
- Subjects will continue to be followed for data points as described in Protocol Section 5.5.2 OFF-PROTOCOL FOLLOW-UP (DISCONTINUATION OF STUDY TREATMENT).
Date relapse or progression first detected:
Enter the date relapse or progression was first detected. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Relapse is defined by either morphological or cytogenetic evidence of acute leukemia or MDS consistent with pre-transplant features, or radiologic evidence of lymphoma, documented or not by biopsy. Progression of disease applies to patients with lymphoproliferative diseases (lymphoma or chronic lymphocytic leukemia) not in remission prior to transplantation. The event is defined as increase in size of prior sites of disease or evidence of new sites of disease, documented or not by biopsy. Institution of any therapy to treat persistent, progressive or relapsed disease, including the withdrawal of immunosuppressive therapy or donor lymphocyte infusion, will be considered evidence of relapse/progression regardless of whether the criteria described above were met.
See Appendix C in the ACCELERATE platform protocol for more detailed definitions of relapse for each disease.
Testing Methods Used to Detect Relapse / Progression
Molecular assessment involves determining whether a molecular marker for the disease exists in the blood or bone marrow. Molecular assessment is the most sensitive method of detection and can indicate known genetic abnormalities associated with the disease for which the HCT was performed. RFLP testing (with PCR amplification) is an example of a molecular test method used to detect BCR/ABL.
Flow cytometry is a method of analyzing peripheral blood, bone marrow, or tissue preparations for multiple unique cell characteristics. Its primary clinical purpose in the setting of leukemia is to quantify blasts in the peripheral blood or bone marrow, or to identify unique cell populations through immunophenotyping. Flow cytometry assessment may also be referred to as “MRD” or minimal residual disease testing.
FISH is a sensitive technique that assesses a large number of cells. This technique uses special probes that recognize and bind to fragments of DNA commonly found in acute leukemia, MDS, CLL, or lymphoma. These probes are mixed with cells from the subject’s blood. A fluorescent “tag” is then used to visualize the binding of the probe to the diseased cells. FISH testing for sex chromosomes after sex-mismatched allogeneic HCT should not be considered disease assessment, as the purpose is to determine donor chimerism. Additionally, the FISH probe panel should reflect the subject’s current disease; FISH may be used as surveillance for changes associated with post-therapy malignancy.
Conventional cytogenetics are performed by culturing cells (growing cells under controlled conditions) until they reach the dividing phase. Techniques are then performed to visualize the chromosomes during cell division so that various bands and reconfigurations can be seen. This is called karyotyping. Banding pattern differentiation and chromosomal reconfiguration demonstrate evidence of disease.
Clinical and hematologic assessments are the least sensitive methods of disease detection. Examples of clinical and hematologic assessments include pathological evaluation (e.g., bone marrow biopsy), laboratory assessment (e.g., CBC, peripheral blood smear), and clinician evaluation and physical examination.
Radiologic assessments are imaging techniques used to assess disease response to transplant. Imaging techniques used to evaluate disease response typically include PET, CT, or MIBG, but may include x-ray, skeletal survey, or ultrasound in some cases.
Was a disease relapse/progression detected by molecular testing (e.g. PCR, NGS):
Was a disease relapse/progression detected via flow cytometry:
Was a disease relapse/progression detected via FISH:
Was a disease relapse/progression detected via conventional cytogenetics:
Was a disease relapse/progression detected by clinical / hematologic assessment:
Was a disease relapse/progression detected by radiologic assessment:
Answer each testing method field with the appropriate response:
- Yes
- No
- Not applicable – testing not performed
Indicate all site(s) of relapse or progression (select all that apply):
- Blood
- Bone marrow
- Cerebral spinal fluid
- Other central nervous system
- Testes
- Lymph nodes
- Skin
- Soft tissue
- Spleen
- Other site
Specify other site:
This field will only appear in the EDC if “Other site” is selected. Specify site of relapse or progression in the text box (up to 200 characters). Persistent disease should not be reported as disease relapse or progression.
Bone Marrow Assessment
Was a bone marrow aspirate performed?:
Indicate if the bone marrow aspirate was performed as “Yes” or “No” at the time of Date relapse or progression first detected. If “Yes,” continue reporting below.
Date of bone marrow aspirate:
This field will only appear in the EDC if “Was a bone marrow aspirate performed?” is answered Yes. Report the date the bone marrow aspirate was performed at the time of relapse or progression. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Blasts in bone marrow aspirate by morphology:
This field will only appear in the EDC if “Was a bone marrow aspirate performed?” is answered Yes. Report the percent blasts in the bone marrow from the bone marrow aspirate in % (up to 5 characters). If analyte result includes a special character or text, report the result as it appears on the lab report (i.e. <1.0).
Was a bone marrow biopsy performed?:
Indicate if the bone marrow biopsy was performed as “Yes” or “No” at the time of Date relapse or progression first detected. If “Yes,” continue reporting below.
Date of bone marrow biopsy:
This field will only appear in the EDC if “Was a bone marrow biopsy performed?” is answered Yes. Report the date the bone marrow biopsy was performed at the time of relapse or progression. Date can either be entered directly in the data field using the DD/MMM/YYYY format, or the calendar date picker can be used.
Blasts in bone marrow biopsy by morphology:
This field will only appear in the EDC if “Was a bone marrow biopsy performed?” is answered Yes. Report the percent blasts in the bone marrow from the bone marrow biopsy in % (up to 5 characters). If analyte result includes a special character or text, report the result as it appears on the lab report (i.e. <1.0).
CCG v1.0 | CRF v1.3
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