RM Gorbacheva Research Institute
Saint Petersburg, 197022, Russia
Location status: Recruiting
Location contact
Alexandr Kulagin
CONTACT
Ivan Moiseev
CONTACT
NCT Number: NCT06477549
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).
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Saint Petersburg, 197022, Russia
Location status: Recruiting
Alexandr Kulagin
CONTACT
Ivan Moiseev
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Days -7 through -6: Bendamustine 90 mg/m2 iv x 2 days
Days -7 through -2: ruxolitinib 5 mg tid per os
Time frame: 2 years
Measure: Kaplan-Meier estimate of either relapse, primary or secondary graft failure or death from all causes
Time frame: 365 days
Cumulative primary and secondary graft failure, competing risk is death and relapse
Time frame: 125 days
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: 100 days
proportion of patients, requiring systemic treatment for bacterial, viral and fungal disease
Time frame: 125 days
Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure
Time frame: 2 years
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
Cumulative incidence of patients with mortality without hematological relapse of malignancy
Time frame: 2 years
Measure: Kaplan-Meier estimate of death from all causes
Time frame: 2 years
Measure: Kaplan-Meier estimate of death, acute GVHD grade III-IV, severe chronic GVHD or relapse
Time frame: 2 years
Cumulative incidence of patients with relapse, competing risk is non-relapse mortality
Contact information is provided by the study sponsor or research team.
IVAN SERGEEVICH MOISEEV
CONTACT
Yulia Vlasova
CONTACT
St. Petersburg State Pavlov Medical University
Other
Randomized Trial of Benadamustine Versus Ruxolitinib With Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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