IIT2022-03-Paquette-GeriBMT: A Phase I Study of De-Escalation of Post-Transplant Cyclophosphamide Dosing in Patients Aged >/= 65 Years Undergoing Conditioning With Fludarabine and Total Body Irradiation 800 cGy
Ronald Paquette
Summary
The purpose of this phase 1 study is to determine the optimal dose of the immune suppressive drug, cyclophosphamide, following standard allogeneic stem cell transplant in patients aged \>/= 65 years with hematologic malignancies.
Description
The patients will receive a standard dose, or a reduced amount of the immune suppressive drug, cyclophosphamide, that is routinely administered after the transplant procedure. The following procedures will be performed: cardiac MRI scans and/or transthoracic echocardiogram (TTE); laboratory tests, geriatric assessments and tests to measure strength and stability. Participation in the study is expected to last up to one year with follow-up visits occurring on Day +30, Day +100, Day +180 and Day +365 following allogenic stem cell transplant.
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient age \>/= 65 years * Patient and related Donor (if applicable) sign the Informed Consent Form for the study. If donor is unrelated, donor does not sign Informed Consent Form and this will not affect recipient study eligibility. * Patient meets standard criteria for allogeneic stem cell transplant * Patient is deemed suitable to receive Flu/TBI 800 conditioning regimen as standard of care transplant * Donor is willing to donate peripheral blood stem cells Exclusion Criteria: * Patient has a diagnosis of myelofibrosis * Patient has high titer antibodies (\>10,000…
Interventions
- DrugCyclophosphamide
Cyclophosphamide will be administered at 50, 40, 32, or 25 mg/k/d intravenous infusion (IV) continuously for two days starting 60-72 hours after transplant.
Location
- Cedars-Sinai Medical CenterLos Angeles, California