Post-Transplant Cyclophosphamide for Older Adults with Blood Cancers

This study is testing different doses of cyclophosphamide, a medicine that helps prevent your body from rejecting a stem cell transplant, in people aged 65 and older with blood cancers (hematologic malignancies). You would receive a standard or reduced dose of cyclophosphamide after your transplant. The main goal is to find the best dose to prevent severe acute GVHD (Graft Versus Host Disease), a common complication where the new immune cells attack your body, within 100 days after transplant. The study plans to enroll 26 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 26 participants. It is a Phase 1 study, meaning it's focused on finding the optimal dose of cyclophosphamide.
What's involved
You would receive cyclophosphamide after your transplant. Procedures include cardiac MRI scans or echocardiograms, laboratory tests, geriatric assessments, and tests to measure strength and stability. Participation is expected to last up to one year.
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up visits on Day +30, Day +100, Day +180, and Day +365 after your transplant.

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NCT05849207

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

Recruiting
PHASE1Ages 65+InterventionalTreatment
Ronald Paquette
~26 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Cyclophosphamide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum grade acute GVHD by day +100 by Modified Keystone Criteria
Measured over 100 days post-transplant
Hematologic Malignancies
1 sites across 1 states
California1
  • Ronald Paquette, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

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Eligibility criteria

Inclusion

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

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.
  • Maximum grade acute GVHD by day +100 by Modified Keystone Criteria100 days post-transplant

    Evaluate the frequency of grade III/IV acute GVHD using Modified Keystone Criteria