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RecruitingInterventionalPhase 1

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

NCT ID: NCT05849207Sponsor: Ronald PaquetteLast updated: 2026-05-07

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

Sex: AllAge: 65 Years and olderHealthy 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 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.

Study locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Recruiting
Clinical Trial Recruitment Navigator · Contact
John Chute, MD · Sub Investigator
Justin Darrah, MD · Sub Investigator
Akil Merchant, MD · Sub Investigator
Noah Merin, MD, PhD · Sub Investigator
Joshua Sasine, MD, PhD · Sub Investigator
Robert Vescio, MD · Sub Investigator
Arash Asher, MD · Sub Investigator
Philip Chang, MD · Sub Investigator
Alan Kwan, MD · Sub Investigator
Stephen Shiao, MD, PhD · Sub Investigator
Hannah Lee, MD · Sub Investigator