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

NCT05849207 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IIT2022-03-PAQUETTE-GERIBMT
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Keywords

Allogeneic Transplantation

Outcome Measures

Primary Outcomes (1)

• Maximum grade acute GVHD by day +100 by Modified Keystone Criteria

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

  100 days post-transplant

Secondary Outcomes (14)

• Time to neutrophil and platelet engraftment

  60 days post-transplant

• Non-Relapse mortality

  100 days post-transplant

• Chronic Graft Versus Host Disease (GVHD) at 1 year

  1-year post-transplant

• Relapse

  1-year post-transplant

• Overall Survival (OS)

  1-year post-transplant

Study Arms (1)

Open Arm

EXPERIMENTAL

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

Drug: Cyclophosphamide

Interventions

Cyclophosphamide DRUG

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.

Open Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ronald Paquette: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Ronald Paquette, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Navigator

CONTACT

310-423-3713; GroupCancerTrialInformation@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Blood and Marrow Transplant Program

Model Details: Open-label trial De-escalation of post-transplant cyclophosphamide dosing

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 8, 2023
• Study Start: October 24, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)