Actively Recruiting
Randomized Trial of Bendamustine Versus Ruxolitinib With Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation
Led by St. Petersburg State Pavlov Medical University · Updated on 2024-06-27
220
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two conditioning treatments for patients undergoing haploidentical hematopoietic stem cell transplantation (HCT) for various blood cancers, including acute myeloid leukemia, acute lymphoblastic leukemia, and myelodysplastic syndromes. This Phase 2 trial aims to compare the addition of bendamustine versus ruxolitinib to the commonly used fludarabine and busulfan regimen. The main goal is to reduce events such as graft failure, relapse, and non-relapse mortality, considering disease risk and donor age as key factors. Participants receive one of two treatment plans. One group gets fludarabine and busulfan along with bendamustine given intravenously before transplantation, followed by cyclophosphamide and oral ruxolitinib after transplantation. The other group receives fludarabine and busulfan with oral ruxolitinib starting before transplantation, continuing with cyclophosphamide and ruxolitinib after transplantation. Each treatment includes specific dosing schedules over days before and after the stem cell transplant. During the study, participants are closely monitored for survival without major complications over two years. Researchers will assess graft failure rates, adverse events, infections, and graft-versus-host disease at various times up to two years. The study includes safety and toxicity checks, infection tracking, and overall survival analysis. Participants' health and response to treatment are regularly evaluated through clinical assessments and laboratory tests throughout the study period.
CONDITIONS
Brief Title
BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must need allogeneic hematopoietic stem cell transplantation with myeloablative conditioning for malignant disease
- Diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, mixed lineage acute leukemia, lymphoblastic lymphoma, chronic myeloid leukemia, myelodysplastic syndromes, or myeloproliferative neoplasm
- Age 18 years or older
- Malignant disease in hematologic response with less than 5% clonal blasts in bone marrow and no clonal blasts in peripheral blood
- Related donor available with 5 to 9 out of 10 HLA matches at HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1
- Peripheral blood stem cells or bone marrow used as graft source
You will not qualify if you...
- Anti-donor anti-HLA antibody titer 5000 or higher at inclusion
- Moderate or severe cardiac disease including ejection fraction under 50%, unstable or severe angina, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, or recent myocardial infarction within 3 months
- Stroke within 3 months before inclusion unless related to the underlying malignancy
- Severe lung dysfunction such as FEV1 or DLCO below 50%, respiratory distress, or need for oxygen support
- Severe organ dysfunction including high AST or ALT over 5 times normal, bilirubin over 1.5 times normal, or creatinine over 2 times normal
- Creatinine clearance less than 40 mL/min
- Uncontrolled bacterial or fungal infection with CRP over 70 mg/L
- Need for vasopressor support at enrollment
- Karnofsky performance score below 70%
- Pregnancy
- Somatic or psychiatric disorder preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 months
Participants receive conditioning with either Bendamustine or Ruxolitinib alongside Fludarabine and Busulfan before stem cell transplantation, followed by Cyclophosphamide and continued Ruxolitinib dosing.
Regular visits during conditioning and post-transplant medication period
Trial Site Locations
Total: 1 location
1
RM Gorbacheva Research Institute
Saint Petersburg, Russia, 197022
Actively Recruiting
Research Team
I
IVAN SERGEEVICH MOISEEV
Y
Yulia Vlasova
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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