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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 (Jun 2026). This Phase 2 trial studies multiple treatments for graft versus host disease.

Phase 2RecruitingNantes University HospitalNCT06252870Data as of Jun 2026Location: France

Treatment: Methotrexate · Post-Transplant Cyclophosphamide · Fludarabine · Cycophosphamide · Anti-Thymoglobulin · Clofarabine · Thiotepa · Busulfan · FludarabineGraft-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.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

MethotrexatePost-Transplant CyclophosphamideFludarabineClofarabineThiotepaBusulfanFludarabine

Other

CycophosphamideAnti-Thymoglobulin

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)

Demographics

Ages ≤ 70

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.

Frequently asked questions

Is NCT06252870 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allograft, bone marrow transplant disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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