Actively Recruiting
BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
Led by St. Petersburg State Pavlov Medical University · Updated on 2024-06-27
220
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have an indication for allogeneic hematopoietic stem cell transplantation with myeloablative conditioning for malignant disease
- Diagnosis of 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
- Availability of a 5-9/10 HLA-matched related donor identical at HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1
- Peripheral blood stem cells or bone marrow as a graft source
You will not qualify if you...
- Anti-donor anti-HLA antibody titer of 5000 or higher at inclusion
- Moderate or severe cardiac disease including ejection fraction less than 50%, unstable or stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, or myocardial infarction within 3 months
- Stroke within 3 months unless related to underlying malignancy
- Severe pulmonary function decrease: FEV1 less than 50%, DLCO less than 50%, respiratory distress, or need for oxygen support
- Severe organ dysfunction: AST or ALT greater than 5 times upper normal limit, bilirubin greater than 1.5 times upper normal limit, creatinine greater than 2 times upper normal limit
- Creatinine clearance less than 40 mL/min
- Uncontrolled bacterial or fungal infection with CRP greater than 70 mg/L
- Requirement for vasopressor support
- Karnofsky index less than 70%
- Pregnancy
- Somatic or psychiatric disorder preventing informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
RM Gorbacheva Research Institute
Saint Petersburg, Russia, 197022
Actively Recruiting
Research Team
I
IVAN SERGEEVICH MOISEEV
CONTACT
Y
Yulia Vlasova
CONTACT
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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