A Phase 2 interventional study of Fludarabine and Bendamustine Hydrochloride in Leukemia, Acute Lymphoblastic, Myeloid Leukemia, Acute and Biphenotypic Acute Leukemia, sponsored by St. Petersburg State Pavlov Medical University. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by St. Petersburg State Pavlov Medical University · Phase 2, Interventional, and Treatment
Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning 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 10-20% of graft failures. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of disease. Furthermore combination of fludarabine and bendamustine was sufficient to facilitate engraftment in patients with chronic lymphocytic leukemia and lymphomas. The aim of the study is to evaluate whether addition of bendamustine to fladarabine and busulfan conditioning reduces the risk of primary graft failure after haploidentical allograft.
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This study's enrollment of 50 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 130 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 +35: Mycophenolate mofetil 45 mg/kg/day, maximum 3 g/day, iv or po x 30 days; Days +5 through +150: Tacrolimus 0.03 mg/kg/day with further correction by concentration
Drug: Fludarabine · Drug: Bendamustine Hydrochloride · Drug: Busulfan · Drug: Cyclophosphamide · Drug: Mycophenolate Mofetil · Drug: Tacrolimus 5Mg Cap
30 mg/m2/day iv x 6 days, days -7 through -2 of HSCT
130 mg/m2 iv x 2 days, Days -7 through -6 of HSCT
1 mg/kg po qid x 3 days, Days -5 through -3
50 mg/kg iv x 2 days, Days +3 through +4
45 mg/kg/day, maximum 3 g/day, iv or po x 30 days, Days +5 through +35
0.03 mg/kg/day iv or po, Days +5 through +100 with with further correction by concentration. Target concentration 5-15 ng/ml.
- Incidence of primary and secondary graft failure
Proportion of patients with primary and secondary graft failure defined by the absence of donor chimerism
Time frame: 100 days
- Incidence of HSCT-associated adverse events (safety and toxicity)
Toxicity assessment is based on NCI CTC AE 5.0 grades. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2016. Transplant-associated microangiopathy incidence assessment is based on Cho et al. criteria. 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: [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
- Incidence of acute GVHD grade II-IV
Cumulative incidence of patients with acute GVHD II-IV grade
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.
Time frame: 365 days
- Non-relapse mortality analysis
Cumulative incidence of patients with mortality without hematological relapse of malignancy
Time frame: 2 years
- Overall survival analysis
Kaplan-Meier estimate of death from all causes
Time frame: 2 years
- Event-free survival analysis
Kaplan-Meier estimate of death or relapse
Time frame: 2 years
- Relapse rate analysis
Cumulative incidence of patients with relapse
Time frame: 2 years
Plan to share: Yes — Request for sharing data with the study plan for the data will be evaluated under common conditions by Pavlov University Ethical Committee.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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St. Petersburg State Pavlov Medical University