Optimizing post-transplant bendamustine plus cyclophosphamide for high‑risk myeloid cancers with a partially mismatched donor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial enrolls patients with high‑risk myeloid malignancies undergoing allogeneic hematopoietic cell transplantation from donors who are not fully HLA matched. The protocol uses post‑transplant bendamustine combined with post‑transplant cyclophosphamide as graft‑versus‑host disease prophylaxis, with abatacept or ruxolitinib included in intervention arms. The primary aim is to reduce severe cytokine release syndromes and incidence of GVHD while preserving graft‑versus‑leukemia effect. Patients receive peripheral blood or bone marrow grafts and are followed for safety and disease outcomes after transplant.

Why it matters

Who can join: the full rules

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

Where it's running

• Pavlov University
  Saint Petersburg, Russia Recruiting

Study contacts

• Study coordinator: Alexandr D Kulagin, MD, Prof
• Email: bmt-director@1spbgmu.ru
• Phone: +78123386265

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.