Recruiting
Phase 1

Cyclophosphamide

Sponsor:

Ronald Paquette

Code:

NCT05849207

Conditions

Hematologic Malignancies

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

Study Details

Brief 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.

Conditions

Hematologic Malignancies

Study ID

NCT05849207

Start date

Oct 24, 2023

Status verified date

Aug, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

26 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open Arm

All patients will receive cyclophosphamide on Day +3 and Day +4 following transplant.

Interventions

Cyclophosphamide

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.

Primary outcome measure

  • Maximum grade acute GVHD by day +100 by Modified Keystone Criteria [ Time Frame: 100 days post-transplant ]

Central Contacts and Locations

Central contacts

Clinical Trials Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

More Information

Sponsor

Ronald Paquette

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Allogeneic Transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ronald Paquette on 2026-08-05.