BeFluBu vs FluBuRux Conditioning in Haploidentical HCT

Launched by ST. PETERSBURG STATE PAVLOV MEDICAL UNIVERSITY · Jun 21, 2024

Keywords

ClinConnect Summary

This clinical trial, called BeFluBu vs FluBuRux Conditioning, is studying two different treatment approaches for patients with certain types of blood cancers, such as acute lymphoblastic leukemia and acute myeloid leukemia. The goal is to find out which method helps prevent complications like graft failure, where the transplanted stem cells do not work as intended. In this trial, researchers will compare a standard treatment with a new approach that includes additional medications to see if it can improve outcomes for patients undergoing a specific type of stem cell transplant from partially matched donors.

To be eligible for this trial, participants must be at least 18 years old and have a qualifying diagnosis that requires a stem cell transplant. They should have a related donor who is a partial match and meet certain health criteria to ensure they can safely undergo the treatment. Participants in the study will receive one of the two treatment methods and will be closely monitored for any side effects or complications. This trial is currently recruiting, and it offers a potential opportunity for patients to receive advanced care while contributing to medical research.

Gender

ALL

Eligibility criteria

• 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