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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
50 mg/m2 iv Days +3 through +4 after allogeneic hematopoietic stem cell transplantation
25 mg/kg iv Days +3 through +4 after allogeneic hematopoietic stem cell transplantation
RM Gorbacheva Research Institute
Saint Petersburg, Russia
Event-free survival analysis [ Time Frame: 1 year ]
Measure: Kaplan-Meier estimate of death or relapse, or graft failure
Time frame: 1 year
- Incidence of Cytokine release syndrome
Proportion of patients with cytokine release syndrome according to ASBMT Consensus Grading for Cytokine Release Syndrome, 2018
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.
Time frame: 100 days
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: 1 year
Relapse rate analysis
Cumulative incidence of patients with relapse
Time frame: 1 year
Non-relapse mortality analysis
Cumulative incidence of patients with mortality without hematological relapse of malignancy
Time frame: 1 year
Overall survival analysis
Kaplan-Meier estimate of death from all causes
Time frame: 1 year
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