NCT04942730CompletedPhase 2
Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)
Source: ClinicalTrials.gov · Last updated 7 May 2024
Brief summary (registry, in English)
Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning 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 10-20% of graft failures. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of disease. Furthermore combination of fludarabine and bendamustine was sufficient to facilitate engraftment in patients with chronic lymphocytic leukemia and lymphomas. The aim of the study is to evaluate whether addition of bendamustine to fladarabine and busulfan conditioning reduces the risk of primary graft failure after haploidentical allograft.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 21 Jun 2021
- Start date
- 21 Jan 2021
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Diseases
- Acute lymphoblastic leukaemia, Myeloproliferative neoplasms, Myelodysplastic syndromes, Acute myeloid leukemia
- NCT number
- NCT04942730
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 50
- From 21 Jan 2021 to the primary completion date, 30 Apr 2024
- 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-HLA antibodies ≥ 5000 at the time of inclusion
Other illness
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Somatic or psychiatric disorder making the patient unable to sign informed consent
Lab values
- Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
- Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits
- Creatinine clearance \< 60 mL/min
Other
- Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
- Respiratory distress \>grade I
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index \<30%
- Pregnancy
Who the study is looking for
- Patients must have an indication for allogeneic hematopoietic stem cell transplantation with myeloablative conditioning for malignant disease
- 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
- No second malignancies requiring treatment
- No severe concurrent illness
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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.