Report therapy given since the date of last report for reasons other than relapse, persistent, or progressive disease. This may include maintenance and consolidation therapy as well as treatment for minimal residual disease. Do not report any therapy given for relapse, persistent, or progressive disease.
Question 98: Was therapy given since the date of the last report for reasons other than relapse, persistent, or progressive disease? (Include maintenance and consolidation therapy)
Indicate whether therapy was given during the reporting period for maintenance or consolidation; this therapy may have been specifically planned as part of the original transplant protocol or determined after transplant. Do not include therapy given for relapse, persistent, or progressive disease. Any post-transplant therapy included as part of the initial transplant protocol should be reported in this area of the form.
Question 99: Specify Therapy (check all that apply)
Indicate which therapies were given since the date of the last report for reasons other than relapse, persistent, or progressive disease.
Systemic therapy: refers to a delivery mechanism where a therapeutic agent is delivered orally or intravenously, enters the bloodstream, and is distributed throughout the body. Indicate whether systemic therapy was given during the reporting period for reasons other than relapse, persistent, or progressive disease and report the systemic therapy given.
Radiation: Radiation therapy uses high-energy radiation to kill cancer cells. External beam radiation is one of the more frequently used types of radiation. In this method, a beam of radiation is delivered to a specific part of the body, such as the mediastinum. Radiation may be planned if bulky disease was present just prior to transplant for a recipient with lymphoma or a solid tumor. Indicate whether radiation therapy was given during the reporting period for reasons other than relapse, persistent, or progressive disease.
Cellular therapy: Cellular therapy refers to the infusion of human or animal derived cells, which may or may not be modified or processed to achieve a specific composition. Examples include CAR T-cell, NK cell, and mesenchymal cell infusions as well as donor cellular infusions. Select this option if the recipient received any form of cellular therapy for reasons other than relapse, persistent, or progressive disease or decreasing / loss of donor chimerism; hematopoietic cell transplantation should not be reported as cellular therapy. Indicate whether a cellular therapy was infused during the reporting period for reasons other than relapse, persistent, or progressive disease .
Blinded randomized trial: A blinded, randomized trial refers to a research treatment protocol in which the participant is assigned to the control arm or investigational group, and the researcher or clinician is not informed whether the subject is receiving the placebo or standard of care versus the investigational therapy. This makes it impossible to report agents or therapies the recipient is receiving. Indicate whether the recipient is receiving therapy on a randomized, blinded clinical trial during the reporting period for reasons other than relapse, persistent, or progressive disease
Other therapy: Indicate whether the recipient received additional therapy for reasons other than relapsed, persistent, or progressive disease which does not fit into the previous categories. Examples may include intrathecal therapy or surgery. Specify the other therapy.
Questions 100 – 101: Specify systemic therapy (check all that apply)
Systemic therapy agents and treatment regimens vary based on disease, prognosis, and protocol. Treatment may consistent of one or multiple drugs, and may be given in an inpatient or outpatient setting; additionally, drugs may be administered on a single day, over consecutive days, or continuously.
Form options are arranged alphabetically. Indicate which systemic therapy agents were administered during the current reporting period for reasons other than relapse, persistent, or progressive disease. If the recipient received a therapeutic agent that is not listed, select Other systemic therapy and specify the therapy.
Question 102: Specify other therapy
Specify other therapy the recipient received additional therapy for reasons other than relapsed, persistent, or progressive disease which does not fit into the previous form categories. Examples may include intrathecal therapy or surgery.
Questions 103 – 104: Did a fecal microbiota transplant (FMT) occur since the date of last report?
Fecal microbiota transplant (FMT) is a procedure where fecal matter is collected from a pre-screened donor and transferred to a recipient by the oral or rectal route (i.e., by nasogastric tube or enema) in order to restore intestinal microbial flora.
Indicate Yes if the recipient received a FMT in the current reporting period. If Yes, report the date of the FMT. If multiple FMTs occurred during the reporting period, report the date of the first procedure.
For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.
If a FMT did not occur or it is not known if one occurred during the current reporting period, select No.
Questions 105 – 106: Specify indication for the FMT
Specify the indication for the FMT. If the indication is not listed, select Other and specify.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| . | . | . | . | . |
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