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Taking people in Saudi ArabiaPhase 3

Compares two drug plans to prevent graft-versus-host disease after transplant in acute leukemia

Tests cyclophosphamide with calcineurin inhibitors against standard drugs in people with acute leukemia.

Key facts

Who runs it
King Faisal Specialist Hospital & Research Center
Where
Riyadh, Saudi ArabiaSee the site
Trial code
Registry title
Comparing Post-Transplant Cyclophosphamide As GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients
Status
Recruiting
Phase
Phase 3
People taking part
264 people, planned
Started
15 Aug 2021
Expected to end
Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cyclophosphamide 50mg
  • Methotrexate
Record updated
13 March 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 14 to 65 with acute leukemia (AML or ALL) in remission who are planning a stem cell transplant from a fully matched family donor.

Age
14 to 65 years
Sex
All sexes can join.
Disease stage
Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) in complete remission, with or without blood count recovery. Active disease is not allowed.
Earlier treatment
A strong (myeloablative) conditioning treatment before the transplant is planned. A fully compatible (8/8) related donor must be willing to donate peripheral blood stem cells.

Main reasons for not taking part

  • Active leukemia
  • Uncontrolled bacterial, viral or fungal infection
  • HIV-1 or -2, HTLV-I or -II, or active hepatitis B or C
  • Pregnancy or breastfeeding
  • Another cancer treated less than 5 years ago (some skin or cervical cancers excepted)

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Active disease
  • Patients with uncontrolled bacterial, viral, or fungal infections
  • Patients seropositive for HIV-1 or -2
  • Patients with active Hepatitis B or C viral replication by PCR
  • History of uncontrolled autoimmune disease or on active treatment
  • Presence of fluid collection (ascites, pleural or pericardial effusion) that interferes with methotrexate clearance or makes methotrexate use contraindicated
  • Women who are pregnant (positive serum or urine βHCG) or breastfeeding
  • 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
  • Karnofsky or Lansky Performance Score < 70%
  • Patients seropositive for HTLV-I or -II

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 14 and 65 years old?

Where in Saudi Arabia

  • King Faisal Specialist Hospital & Research CenterRiyadh, Saudi ArabiaContact: Riad O El Fakih, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm 1: InterventionTreatment being tested

    Peripheral blood matched related donor HCT, using myeloablative conditioning regimen (IV Busulfan/IV Fludarabine for AML, IV VP16/TBI for ALL) HCT with cyclophosphamide, and oral tacrolimus (or another calcineurin inhibitor if intolerant for tacrolimus) for GVHD prophylaxis. Cyclophosphamide will be given at a dose of 50 mg/kg/day IV on Day +3 and Day +5 post stem cell infusion (only 2 doses).

    Treatment: Cyclophosphamide 50mg

  • Arm 2: Standard of CareExisting treatment, for comparison

    Peripheral blood matched related donor HCT, using myeloablative conditioning regimen (IV Busulfan/IV Fludarabine for AML, IV VP16/TBI for ALL) HCT with methotrexate, and oral tacrolimus (or another calcineurin inhibitor if intolerant for tacrolimus) for GVHD prophylaxis

    Treatment: Methotrexate

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Compares two drug plans to prevent graft-versus-host disease after transplant in acute leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04314219, who can take part
Record updated
13 March 2025