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

Description

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.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.

Trial Eligibility

Inclusion Criteria: * Patient age \>/= 65 years * Patient has a related donor who is a human leukocyte antigens (HLA) haploidentical match * Patient and Donor sign the Informed Consent Form for the study * 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 (PBSC) Exclusion Criteria: * Patient has a diagnosis of myelofibrosis * Patient has high titer antibodies (\>10,000 mean fluorescent intensity) against one or more donor HLA antigens * Patient has undergone prior autologous or allogeneic stem cell transplant * Inability to collect at least 3 x 10\^6 CD34+ PBSCs/kg recipient weight from the donor * Requiring sedation for cardiac MRIs. * Prohibited Implants and/or Devices: * Mechanical, magnetic or electrical activated implants (i.e. cardiac pacemakers, neurostimulators and infusion pumps) * Ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged. * Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.

Study Info

Interventions

Locations Recruiting

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