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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Ronald Paquette
Study ID
NCT05849207
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 24, 2023
Status verified
May 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Open Arm
    All patients will receive cyclophosphamide on Day +3 and Day +4 following transplant.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
13104232133
John Chute, MD (SUB_INVESTIGATOR)
Justin Darrah, MD (SUB_INVESTIGATOR)
Akil Merchant, MD (SUB_INVESTIGATOR)
Noah Merin, MD, PhD (SUB_INVESTIGATOR)
Joshua Sasine, MD, PhD (SUB_INVESTIGATOR)
Robert Vescio, MD (SUB_INVESTIGATOR)
Arash Asher, MD (SUB_INVESTIGATOR)
Philip Chang, MD (SUB_INVESTIGATOR)
Alan Kwan, MD (SUB_INVESTIGATOR)
Stephen Shiao, MD, PhD (SUB_INVESTIGATOR)
Hannah Lee, MD (SUB_INVESTIGATOR)

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By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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