NCT04943757

Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies

Graft-versus-host Disease Prophylaxis With Combination of Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies (PTBCy)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Prognosis of patients undergoing salvage allogeneic stem cell transplantation for refractory leukemia or other refractory myeloid malignanies is poor. 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. On the other hand post-transplantation cyclophocphamide was reported to abort cytokine release syndrome that sometimes occurs after graft transfusion in patients after haploidentical graft transfusion. The aim of this study is to evaluate if the combination of post-transplantation 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

• Myeloid Leukemia, Acute
• Chronic Myeloid Leukemia
• Myelodysplastic Syndromes
• Myeloproliferative Neoplasm

Interventions

Type	Name	Description
DRUG	Bendamustine Hydrochloride	50 mg/m2 iv Days +3 through +4 after allogeneic hematopoietic stem cell transplantation
DRUG	Cyclophosphamid	25 mg/kg iv Days +3 through +4 after allogeneic hematopoietic stem cell transplantation

Timeline

• Start date: 2021-01-21
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2021-06-29
• Last updated: 2024-10-15

Locations

1 site across 1 country: Russia