Question 27: Was therapy given since the date of last report for reasons other than relapse or progressive disease? (Include any maintenance and consolidation therapy.)
Indicate if the recipient received treatment post-Infusion for reasons other than relapse, progressive, or persistent disease (excluding minimal residual disease (MRD)) during the current reporting period. Recipients are generally transplanted under a specific protocol that defines radiation and/or systemic therapy the recipient is intended to receive as a preparative regimen prior to the HCT or cellular therapy; infection and GVHD prophylaxis to be administered pre- and/or post-HCT; as well as any systemic therapy, radiation, and/or other treatments to be administered post-HCT or cellular therapy as planned (or maintenance) therapy. Planned (maintenance or consolidation) therapy is given to assist in prolonging a remission. Planned therapy may be described in a research protocol or standard of care protocol and these should be referred to when completing this section. If post-transplant therapy is given as prophylaxis or maintenance for recipients in CR, or as preemptive therapy for recipients with minimal residual disease, consider this “planned therapy,” even if this was not documented prior to the transplant. For example, if a physician decides to put the recipient on rituximab maintenance therapy post-HCT or cellular therapy, even if it the intent wasn’t documented prior to transplant, report it in this section of the form. Do not include any treatment administered as a result of relapse, progression, or persistent disease (excluding MRD).
If planned therapy, including therapy given for maintenance or consolidation, was given during the reporting period, report “yes” continue with question 28. If “no” or “unknown,” continue skip questions 28-42.
Question 28: 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 as planned treatment post-HCT or cellular therapy (including maintenance and consolidation treatments) during the reporting period and continue with question 29.
If systemic therapy was not given as planned therapy during the reporting period, report “no and skip questions 29-38.
Question 29: Chemotherapy
Indicate whether chemotherapy was given as planned treatment post-HCT or cellular therapy (including maintenance and consolidation treatments) during the reporting period. Do not report immune therapy / monoclonal antibodies (e.g., rituximab) as these treatments will be captured in questions 30-38.
Questions 30-38: Immune therapy/monoclonal antibody (mAb)
Indicate whether immune therapy/monoclonal antibody (mAb) was given as planned treatment post-HCT or cellular therapy (including maintenance and consolidation treatments) during the reporting period.
If “yes,” report the treatment(s) given using questions 31-38. If the recipient received a monoclonal antibody which is not listed, report “Other mAb” for question 35 and specify any other monoclonal antibodies given in question 36. If the recipient received an immune therapy which is not listed, report “yes” in question 37 and specify the other immune therapy in question 38.
If “no,” skip questions 31-38.
Question 39: Radiation
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 which 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 received radiation as planned therapy post-HCT or cellular therapy (including maintenance and consolidation treatments) during the reporting period. If not, report “no.”
Question 40: 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 planned therapy post-HCT (including maintenance and consolidation treatments) during the reporting period. If not, report “no.”
Question 41-42: Other therapy
Indicate if the recipient received any other treatment as planned therapy post-HCT (including maintenance and consolidation treatments). If “yes,” specify the type of treatment administered using question 42. If “no,” skip question 42.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| . | . | . | . | . |
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