Optimizing post-transplant bendamustine plus cyclophosphamide for high‑risk myeloid cancers with a partially mismatched donor
Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor (APTBCy)
This trial tests whether giving bendamustine plus cyclophosphamide after transplant (with possible abatacept or ruxolitinib) can reduce dangerous cytokine release and graft‑versus‑host disease for people with high‑risk myeloid malignancies who have a partially HLA‑mismatched donor.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | St. Petersburg State Pavlov Medical University Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT07238712 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with high‑risk or refractory myeloid malignancies who need an allogeneic stem cell transplant and have a donor who is not fully HLA matched (less than 10/10 match), using peripheral blood or marrow grafts.
Not a fit: Patients with well‑matched (10/10) donors, non‑myeloid malignancies, or contraindications to bendamustine, cyclophosphamide, abatacept, or ruxolitinib are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the regimen could lower rates of life‑threatening cytokine release and severe GVHD, making allogeneic transplant safer for high‑risk myeloid patients with partially mismatched donors.
How similar studies have performed: Previous reports showed post‑transplant bendamustine can achieve strong graft‑versus‑leukemia responses but was associated with frequent cytokine release syndrome, and early data suggest combining bendamustine with post‑transplant cyclophosphamide may retain efficacy with fewer severe immune complications.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Saint Petersburg
- Pavlov University — Saint Petersburg, Russia (Recruiting)
Study contacts
- Study coordinator: Alexandr D Kulagin, MD, Prof
- Email: bmt-director@1spbgmu.ru
- Phone: +78123386265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.