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NCT05849207PHASE1Recruiting

Post-Transplant Cyclophosphamide in Patients Aged >/= 65 Years Undergoing Haploidentical Transplant

Ronald Paquette

Start Date

10/24/2023

Completion Date

7/1/2028

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.

Eligibility Criteria

Age Range: 65 years to No maximum

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 mean fluorescent intensity) against one or more donor HLA antigens * Patient has undergone prior autologous or allogeneic stem cell transplant * 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.

Interventions

DRUG

Cyclophosphamide

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Conditions

Hematologic Malignancies

Locations

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States