Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cyclophosphamide 50mg, Methotrexate.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia (ALL) in Complete Remission, Acute Myeloid Leukemia (AML) in Remission. Basic parameters: 14 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing Post-Transplant Cyclophosphamide with Calcineurin Inhibitors As a GVHD Prophylaxis to Standard Care of Methotrexate and Calcineurin Inhibitors for Acute Leukemia Incorporating Patient Pharmacogenomics Profiling
Overview
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.
Detailed 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.
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
Primary outcome measures
- GRFS (GVHD-free/relapse-free survival) [Time frame: One-year post-transplant]
Secondary outcome measures (2)
- Acute Graft versus Host Disease (aGVHD) [Time frame: 100 Day post transplant]
- Chronic Graft versus Host Disease (cGVHD) [Time frame: One year Post-transplant]
Eligibility criteria
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%.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Saudi Arabia · 1 center
- King Faisal Specialist Hospital & Research Center — Riyadh
Identifiers
NCT: NCT04314219 · 2181104 · Saudi FDA