Q43-88: Disease Relapse or Progression Post-HCT / Post-Infusion

Question 43: Was a disease relapse or progression detected since the date of last report?

Refer to the international working group criteria provided in CLL Response Criteria section of the Forms Instructions Manual for more information on how to determine recurrence or progression of disease. If the recipient met the criteria for relapse or progression during the reporting period, report “yes” and continue with question 44. Do not report persistent disease in this section of the form.

If the recipient’s disease did not relapse or progress during the reporting period, report “no” and skip questions 44-54. Questions 44-52 are meant to capture the recipient’s molecular, immunophenotypic, and cytogenetic status at the time of hematologic relapse / progression. Therefore, these questions will only be completed if the recipient has met the criteria for clinical/hematologic relapse or progression during the reporting period.

Question 44-45: Was a disease relapse or progression detected by molecular testing (e.g. PCR)?

If relapse or progression was identified by molecular testing, report “yes” and indicate the sample collection date in question 45. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Only consider testing performed via molecular methods (e.g., PCR or other methods of equal or greater sensitivity) when completing question 44. Do not consider lower sensitivity testing such as FISH, flow cytometry, karyotyping, or clinical/hematologic methods.

If relapse or progression was not identified by molecular testing, report “no” and skip question 45.

Question 46-47: Was a disease relapse or progression detected via flow cytometry?

If relapse or progression was identified by flow cytometry (immunophenotyping), report “yes” and indicate the sample collection date in question 47. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

If relapse or progression was not detected by flow cytometry, report “no” and skip question 47.

Question 48: Was a disease relapse or progression detected by cytogenetic testing (karyotyping or FISH)?

Indicate if cytogenetic studies (karyotyping or FISH) were obtained at the time of hematologic relapse / progression. If either of these methods detected relapse / progression, report “yes” and continue with question 49. If “no,” skip questions 49-52.

Question 49-50: Was a disease relapse or progression detected via FISH?

If FISH studies identified disease relapse or progression, report “yes” and indicate the date of sample collection in question 50. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

If FISH studies did not identify disease relapse or progression, report “no” and skip question 50. Examples of this include: no FISH studies performed or FISH sample was inadequate.

Question 51-52: Was a disease relapse or progression detected via karyotyping?

If conventional cytogenetics identified disease relapse or progression, indicate “yes” and report the date of sample collection in question 52. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

If conventional cytogenetics did not identify disease relapse or progression, report “no” and skip question 52. Examples of this include: no conventional cytogenetics performed or conventional cytogenetic culture failed.

Question 53-54: Was a disease relapse or progression detected by clinical/hematologic assessment?

Clinical and hematologic assessments are the least sensitive methods of establishing a patient’s disease status. Examples of those include: pathologic evaluation (e.g., bone marrow biopsy), radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), and laboratory assessment (e.g., CBC, peripheral blood smear), in addition to clinician evaluation and physical examination.

If clinical and/or hematologic assessments identified disease relapse or progression, report “yes” and indicate the date of assessment in question 54. Enter the date of the clinical/hematologic disease assessment that documented disease relapse or progression. Report the date disease was detected by radiographic examination (e.g., CT, MRI, PET, or PET/CT scans), bone marrow examination, peripheral blood assessment, or clinical assessment. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

If clinical and/or hematologic assessments did not identify disease relapse or progression, report “no” and skip question 54.

Question 55: Was any therapy given for relapse or progressive disease since the date of last report?

*Therapy for Persistent Disease
Report treatment for persistent disease (excluding MRD) in questions 55-88. Do not include therapy which has already been reported in questions 27-42 (planned therapy including maintenance and consolidation) unless the treatment is continued after the recipient’s disease has relapsed or progressed.

Systemic therapy, radiation, and/or other treatments may be administered for relapse or progressive disease. Indicate if the recipient received treatment post-infusion for relapse or progressive disease since the date of last report.

Question 56: Date started

Enter the date the recipient first received treatment for relapse, progressive, or persistent (excluding MRD) disease during the current reporting period. If the therapy reported in this section is continued from a prior reporting period, leave question 56 blank and override the validation error using the code “Unable to Answer.” If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Question 57: Systemic therapy

Systemic therapy is delivered via the blood stream and distributed throughout the body. Therapy may be injected into a vein or given orally. Common systemic therapies used to treat CLL include chemotherapy and monoclonal antibodies.

Report “yes” if systemic therapy was given for relapsed, progressive, or persistent (excluding MRD) disease during the reporting period and continue with question 58.

If systemic therapy was not given for relapsed, progressive, or persistent (excluding MRD) disease during the reporting period, report “no and skip questions 58-83.

Questions 58-83: Specify systemic therapy

Report “yes” or “no” for each chemotherapy and immunotherapy drug listed on the form. If the recipient received a chemotherapy treatment that is not listed, report “yes” for “other treatment” and specify the treatment in question 83. Report the generic name of the agent, not the name brand.

Question 84: Radiation therapy

Radiation therapy utilizes high-energy x-rays, gamma rays, electron beams, or proton beams to kill cancer cells. For CLL, radiation therapy may be used to kill cells that have invaded other tissues and lymph nodes. Radiation therapy may be given in conjunction with systemic chemotherapy or as a separate line of therapy.

Report “yes” if the recipient was given treatment for relapsed, progressive, or persistent (excluding MRD) disease during the reporting period. If not, report “no.”

Question 85: Cellular therapy

Cellular therapy treatment strategies include isolation and transfer of specific stem cell populations, administration of effector cells (e.g., cytotoxic T-cells), induction of mature cells to become pluripotent cells, and reprogramming of mature cells (e.g., CAR T-cells).

Report “yes” if the recipient received cellular therapy as treatment for relapsed, progressive, or persistent (excluding MRD) disease during the reporting period. If not, report “no.”

Question 86: Withdrawal of immunosuppression

Immunosuppressive medications may be tapered or entirely withdrawn in order to promote a graft vs leukemia effect in the setting of relapsed, progressive, or persistent (excluding MRD) disease post-HCT.

If immunosuppression is reduced or stopped during the reporting period in order to treat disease, report “yes.” If not, report “no.”

Questions 87-88: Other therapy

Indicate if the recipient received any other treatment for relapsed, progressive, or persistent (excluding MRD) disease during the reporting period. If “yes,” specify the type of treatment administered using question 88. If “no,” skip question 88.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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