NCT07238712

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Prognosis of patients undergoing allogeneic stem cell transplantation (HCT) for high-risk myeloid malignancies, including refractory acute myeloid leukemia, with standard HCT technologies have relatively poor prognosis with 10-30% long-term disease-free survival. One of the approaches to augment graft-versus-leukemia effect the use of post-transplantation bendamustine in graft-versus-host disease prophylaxis. Despite high frequency of responses and durable remissions after this approach majority of patients develop a serious complication - cytokine release syndrome, which can be life-threatening in some patients. The combination bendamustine (PTB) and post-transplantation cyclophosphamide (PTCY) facilitates comparable graft-versus leukemia effect to PTB, but with better safety profile and reduced incidence of severe cytokine release syndrome.

Conditions

• Acute Myeloid Leukemia (AML)
• Chronic Myeloid Leukemia
• Myelodysplastic Syndromes (MDS)
• Myeloprolipherative Neoplsm
• Atypical Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Ruxolitinib	; Days -1 through +21: ruxolitinib 10 mg/kg/day p.o.
DRUG	Abatacept (Orencia)	Days -1,+5, +14, +21 abatacept 10 mg/kg/day i.v.

Timeline

• Start date: 2025-05-10
• Primary completion: 2026-12-10
• Completion: 2026-12-10
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

1 site across 1 country: Russia