A Phase 2 interventional study of Bendamustine Hydrochloride and Ruxolitinib in Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia and Biphenotypic Acute Leukemia, sponsored by St. Petersburg State Pavlov Medical University. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by St. Petersburg State Pavlov Medical University · Phase 2, Interventional, and Treatment
Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning intensity and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 7-20% of graft failures in different diseases. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of diseases. In two previously completed trials of addition of either bendamustine and ruxolitinib to conditioning we observed low rates of primary graft failure with both approaches. The study is the direct randomized comparisons of these two approaches with the primary aim of reducing composite events of primary graft failure, relapse and non-relapse mortality. The stratas for the study are Disease Risk Index (DRI) and the age of the haploidentical donor (\<35 vs ≥35).
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 220 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →St. Petersburg State Pavlov Medical University is the lead sponsor of 50 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days; Days -7 through -6: Bendamustine 90 mg/m2 iv x 2 days; Days -5 through -3: Busulfan 1 mg/kg po qid x 3 days;Days +3 through +4: Cyclophosphamide 50 mg/kg iv x 2 days; Days +5 through +20: ruxolitinib 5 mg tid per os; Days +21 through 150: ruxolitinib 5 mg bid per os.
Drug: Bendamustine Hydrochloride
Days -7 through -2: Fludarabine 30 mg/m2/day iv x 6 days; Days -7 through -2: ruxolitinib 5 mg tid per os; Days -5 through -3: Busulfan 1 mg/kg po qid x 3 days; Days +3 through +4: Cyclophosphamide 50 mg/kg iv x 2 days; Days +5 through +20: ruxolitinib 5 mg tid per os; Days +21 through 150: ruxolitinib 5 mg bid per os.
Drug: Ruxolitinib
Days -7 through -6: Bendamustine 90 mg/m2 iv x 2 days
Days -7 through -2: ruxolitinib 5 mg tid per os
Event-free survival
Measure: Kaplan-Meier estimate of either relapse, primary or secondary graft failure or death from all causes
Time frame: 2 years
Cumulative incidence of primary and secondary graft failure
Cumulative primary and secondary graft failure, competing risk is death and relapse
Time frame: 365 days
Incidence of HSCT-associated adverse events (safety and toxicity)
Toxicity assessment is based on presence of NCI CTC AE 5.0 event grades 3-5. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2020. Transplant-associated microangiopathy incidence assessment is based on Harmonization criteria by Schoettler et al. All toxicity measurements will be aggregated as severity scores
Time frame: 125 days
Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence
proportion of patients, requiring systemic treatment for bacterial, viral and fungal disease
Time frame: 100 days
Cumulative incidence of acute GVHD grade II-IV
Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure
Time frame: 125 days
Incidence of moderate and severe chronic GVHD
Cumulative incidence of patients with moderate and severe chronic GVHD according to NIH 2015 criteria, competing risk is death, relapse and primary graft failure
Time frame: 2 years
Non-relapse mortality analysis
Cumulative incidence of patients with mortality without hematological relapse of malignancy
Time frame: 2 years
Overall survival analysis
Measure: Kaplan-Meier estimate of death from all causes
Time frame: 2 years
GVHD-relapse-free survival analysis
Measure: Kaplan-Meier estimate of death, acute GVHD grade III-IV, severe chronic GVHD or relapse
Time frame: 2 years
Relapse cumulative incidence analysis
Cumulative incidence of patients with relapse, competing risk is non-relapse mortality
Time frame: 2 years
Plan to share: Yes — Written proposal to the department of scientific affairs of Pavlov University with a subsequent signed contract for research
Supporting information: Study protocol
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St. Petersburg State Pavlov Medical University