Using cyclophosphamide for older patients after stem cell transplant
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
PHASE1 · Cedars-Sinai Medical Center · NCT05849207
This study is testing the best dose of cyclophosphamide for older patients receiving a specific type of stem cell transplant to see how it affects their recovery and health.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center (other) |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05849207 on ClinicalTrials.gov |
What this trial studies
This phase 1 study aims to find the optimal dose of cyclophosphamide, an immune suppressive drug, for patients aged 65 and older who are undergoing haploidentical stem cell transplantation for hematologic malignancies. Participants will receive either a standard or reduced dose of cyclophosphamide following their transplant. The study will include various assessments such as cardiac MRI scans, laboratory tests, and geriatric evaluations to monitor the patients' health and response to treatment. Follow-up visits will occur at specified intervals up to one year post-transplant.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 years and older who are eligible for allogeneic stem cell transplantation.
Not a fit: Patients with myelofibrosis or those who have undergone prior stem cell transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve transplant outcomes and reduce complications for older patients with hematologic malignancies.
How similar studies have performed: Other studies have explored the use of cyclophosphamide in transplant settings, but this specific approach for older patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Ronald Paquette, MD — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trials Navigator
- Email: GroupCancerTrialInformation@cshs.org
- Phone: 310-423-3713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hematologic Malignancies, Allogeneic Transplantation