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Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients

NCT04314219 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2025-03-13

No results posted yet for this study

Summary

This randomized clinical trial will evaluate two approaches of GvHD prophylaxis; the standard of care GVHD prophylaxis regimen (methotrexate/calcineurin inhibitors) and post-transplant cyclophosphamide with calcineurin inhibitors for their efficacy as a new GVHD prophylaxis strategy.

Conditions

  • Acute Lymphoblastic Leukemia (ALL) in Complete Remission
  • Acute Myeloid Leukemia (AML) in Remission

Interventions

DRUG

Cyclophosphamide 50mg

Cyclophosphamide as GVHD prophylaxis will be on day +3 and day +5

DRUG

Methotrexate

Methotrexate as GVHD prophylaxis will be on day +1, day +3, and day +6

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Riad O El Fakih, MD · KFSH&RC

  • Mahmoud D Aljurf, MD, MPH · KFSH&RC

  • Marwan Y Shaheen, MD · KFSH&RC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-15
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04314219 on ClinicalTrials.gov