NCT06477549RecruitingPhase 2
BeFluBu vs FluBuRux Conditioning in Haploidentical HCT
Randomized Trial of Benadamustine Versus Ruxolitinib With Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation
Source: ClinicalTrials.gov · Last updated 27 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 21 Jun 2024
- Start date
- 21 Jun 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Diseases
- Acute lymphoblastic leukaemia, Myeloproliferative neoplasms, Myelodysplastic syndromes, Acute myeloid leukemia
- NCT number
- NCT06477549
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 220
- From 21 Jun 2024 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Titer of anti-donor anti-HLA antibodies ≥ 5000 at the time of inclusion
Other illness
- Stroke within 3 months of inclusion, unless related to the underlying malignancy
- Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP\> 70 mg/L
- Somatic or psychiatric disorder making the patient unable to sign informed consent
Lab values
- Moderate or severe cardiac disease: ejection fraction \<50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, myocardial infarction within 3 months before inclusion
- Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits
- Creatinine clearance \< 40 mL/min
Other
- Severe decrease in pulmonary function: FEV1 \<50% or DLCO\<50% of predicted or respiratory distress or need for oxygen support;
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index \<70%
- Pregnancy
Who the study is looking for
- Patients must have an indication for allogeneic hematopoietic stem cell transplantation with myeloablative conditioning for malignant disease
- Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, mixed lineage acute leukemia, lymphoblastic lymphoma, chronic myeloid leukemia, myelodysplastic syndromes, myeloprolipherative neoplasm
- Age ≥18
- Malignant disease in hematologic response: \<5% of clonal blasts in the bone marrow and no clonal blasts in peripheral blood.
- Patients with 5-9/10 HLA-matched related donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.
- Peripheral blood stem cells or bone marrow as a graft source
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| RM Gorbacheva Research Institute Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.