Comparing Post-Transplant Cyclophosphamide as GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients (PTCy-PMAT)

  • STATUS
    Recruiting
  • End date
    Dec 29, 2026
  • participants needed
    264
  • sponsor
    King Faisal Specialist Hospital & Research Center
Updated on 23 April 2022

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.

Description

An open-label randomized clinical trial will be performed. Eligible patients are females and males, between 14 and 65 years undergoing allo-HCT for treatment of Acute Leukemia (AML or ALL). Patients must have a matching related peripheral blood stem cell donor. Patients from or referred to the KFSH&RC for allogeneic transplant consideration will be offered the opportunity to participate in this trial.

Treatment Description:

Patients will be randomized on one of the arms; an intervention or a standard of care arm.

Details
Condition Acute Lymphoblastic Leukemia (ALL) in Partial Remission, Acute Lymphoblastic Leukemia (ALL) in Complete Remission, Acute Myeloid Leukemia (AML) in Remission
Treatment methotrexate, Cyclophosphamide 50mg
Clinical Study IdentifierNCT04314219
SponsorKing Faisal Specialist Hospital & Research Center
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with Acute Leukemias (AML, ALL) in morphologic complete remission with or without hematologic recovery
Patients must have a fully matched (8/8) related donor willing to donate peripheral blood stem cells and must meet institutional criteria for donation
Planned Myeloablative conditioning regimen
Cardiac function: ejection fraction at rest ≥ 50% by MUGA or TTE
Estimated creatinine clearance greater than 50 mL/minute
Pulmonary function: DLCO ≥ 50% (adjusted for hemoglobin), and FVC and FEV1 ≥ 50%
Liver function: total bilirubin < 2x the upper limit of normal (unless elevated bilirubin is attributed to Gilbert's Syndrome) and ALT/AST < 2.5x the upper normal limit
Signed informed consent

Exclusion Criteria

Karnofsky or Lansky Performance Score < 70%2
Active disease
Patients with uncontrolled bacterial, viral or fungal infections
Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
Patients seropositive for HIV-1 or -2
Patients seropositive for HTLV-I or -II
Patients with active Hepatitis B or C viral replication by PCR
Women who are pregnant (positive serum or urine βHCG) or breastfeeding
Females with childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation
History of uncontrolled autoimmune disease or on active treatment
Patients with prior malignancies,except resected non-melanoma skin cancer or treated cervical carcinoma in situ; cancer treated with curative intent ≥ 5 years previously will be allowed; cancer treated with curative intent < 5 years previously will not be allowed
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