Comparing two conditioning regimens for haploidentical stem cell transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare two different conditioning regimens, BeFluBu and FluBuRux, in patients undergoing haploidentical hematopoietic stem cell transplantation for various hematologic malignancies. The study focuses on reducing the rates of primary graft failure, relapse, and non-relapse mortality by evaluating the effectiveness of these regimens. Patients will be randomized into two groups based on their disease risk index and the age of their haploidentical donor. The trial includes patients with specific hematologic conditions who meet the eligibility criteria for transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Titer of anti-donor anti-HLA antibodies ≥ 5000 at the time of inclusion
* 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
* Stroke within 3 months of inclusion, unless related to the underlying malignancy
* Severe decrease in pulmonary function: FEV1 \<50% or DLCO\<50% of predicted or respiratory distress or need for oxygen support;
* 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
* Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP\> 70 mg/L
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<70%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent

Where it's running

• RM Gorbacheva Research Institute
  Saint Petersburg, Russia Recruiting

Study contacts

• Study coordinator: Ivan Sergeevich Moiseev
• Email: moisiv@mail.ru
• Phone: 0079217961951

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.