Using cyclophosphamide for older patients after stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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: 310-423-5842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.