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Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor

RECRUITINGPhase 2Sponsored by St. Petersburg State Pavlov Medical University
Actively Recruiting
PhasePhase 2
SponsorSt. Petersburg State Pavlov Medical University
Started2025-05-10
Est. completion2026-12-10
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

Summary

Optimization of bendamustine-containg graft-versus-host disease (GVHD) prophylaxis to reduce the incidence of secondary haemophagocytic lymphohistiocytosis and GVHD

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
Inclusion Criteria:

* Patients with indication for allogeneic hematopoietic stem cell transplantation
* Patients with \<10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.
* Peripheral blood stem cells or bone marrow as a graft source
* Diagnosis:

Acute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardless of blast count in bone marrow Treatment-related myelodysplastic syndrome Second or subsequent allogeneic HCT after relapse of a myeloid malignancy Chronic myelomonocytic leukemia Myeloprolipherative neoplasms, unclassifiable

\- No severe concurrent illness

Exclusion Criteria:

* Patients with indication for allogeneic hematopoietic stem cell transplantation
* Patients with \<10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.
* Peripheral blood stem cells or bone marrow as a graft source
* Diagnosis:

Acute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardless of blast count in bone marrow Treatment-related myelodysplastic syndrome Second or subsequent allogeneic HCT after relapse of a myeloid malignancy Chronic myelomonocytic leukemia Myeloprolipherative neoplasms, unclassifiable

\- No severe concurrent illness

Conditions6

Acute Myeloid Leukemia (AML)Atypical Chronic Myeloid LeukemiaCancerChronic Myeloid LeukemiaMyelodysplastic Syndromes (MDS)Myeloprolipherative Neoplsm

Interventions2

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