OncoMatch/Clinical Trials/NCT06252870
Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation
Is NCT06252870 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for graft versus host disease.
Treatment: Methotrexate · Post-Transplant Cyclophosphamide · Fludarabine · Cycophosphamide · Anti-Thymoglobulin · Clofarabine · Thiotepa · Busulfan · Fludarabine — Graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation (allo-CSH). Recently, in the context of semi-identical (=haploidentical) HLA donors, but also of compatible HLA donors, the use of cyclophosphamide (CY) administered in high doses at early post-transplant (PT) (=PTCY) (Days +3 and +4 or +5) has shown excellent control of acute and chronic GVH, even enabling the discontinuation of other immunosuppressive drugs administered after allo-CSH (ciclosporin, mycophenolate mofetyl (MMF) or Cellcept). This step has already been taken in the context of allo-CSH with myeloablative conditioning (MAC), which is a minoritary conditioning in adults. However, in the context of allo-CSH with reduced-intensity conditioning (RIC), which predominates in adults, this strategy seems insufficient to prevent the risk of GVHD. The idea of reducing the use of immunosuppressants in the context of RIC/HLA-compatible transplants seems, however, still relevant, in order to reduce their adverse effects, improve patients' quality of life and enhance the reconstitution of the post-transplant immune system.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: allograft
History of allograft
Cannot have received: bone marrow transplant
Bone marrow transplant
Lab requirements
Kidney function
creatinine clearance ≥ 50 ml/min (MDRD method)
Liver function
transaminases ≤ 5 times normal and bilirubin ≤ 2 times normal
Cardiac function
systolic ejection fraction ≥ 50% by transthoracic ultrasound or by isotopic method; no NYHA II, III or IV heart failure; no active rhythmic, valvular or ischemic heart disease or anteriority
Cardiac: systolic ejection fraction < 50% by transthoracic ultrasound or by isotopic method (isotope gamma angiography), NYHA II, III or IV heart failure, active rhythmic, valvular or ischemic heart disease or anteriority; Hepatic: transaminases greater than 5 times normal or bilirubin greater than 2 times normal; Renal: creatinine clearance < 50 ml/min (assessment with MDRD method)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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