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
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.
Detailed 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.
Arms & 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.
Outcome measures
Primary
Maximum grade acute GVHD by day +100 by Modified Keystone Criteria
Evaluate the frequency of grade III/IV acute GVHD using Modified Keystone Criteria
Time frame: 100 days post-transplant
Secondary
Time to neutrophil and platelet engraftment
Time frame: 60 days post-transplant
Non-Relapse mortality
Time frame: 100 days post-transplant
Chronic Graft Versus Host Disease (GVHD) at 1 year
Time frame: 1-year post-transplant
Relapse
Time frame: 1-year post-transplant
Overall Survival (OS)
Time frame: 1-year post-transplant
Graft Versus Host Disease (GVHD)-free and Relapse Free Survival
Time frame: 1-year post- transplant
Change in cardiac function
Time frame: From 60 days prior to transplant to 365 days post-transplant
Change in active daily living
Time frame: From 60 days prior to transplant to 365 days post-transplant
Change in function
Time frame: From 60 days prior to transplant to 365 days post-transplant
Change in pain
Time frame: From 60 days prior to transplant to 365 days post-transplant
Change in physical function
Time frame: From 60 days prior to transplant to 365 days post-transplant
Change in grip strength
Time frame: From 60 days prior to transplant to 365 days post-transplant
Change in cognitive function
Time frame: From 60 days prior to transplant to 365 days post-transplant
Change in mental health
Time frame: From 60 days prior to transplant to 365 days post-transplant
Eligibility criteria
Study locations (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048