Comparing two conditioning regimens for haploidentical stem cell transplantation
Randomized Trial of Benadamustine Versus Ruxolitinib With Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation
PHASE2 · St. Petersburg State Pavlov Medical University · NCT06477549
This study is testing two different treatment plans for patients getting stem cell transplants from partially matched donors to see which one works better in preventing complications like graft failure and relapse.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | St. Petersburg State Pavlov Medical University (other) |
| Drugs / interventions | ruxolitinib, Fludarabine |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT06477549 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with specific hematologic malignancies who require allogeneic stem cell transplantation and have a haploidentical donor.
Not a fit: Patients with severe cardiac disease or high levels of anti-donor antibodies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes in stem cell transplantation, reducing graft failure and mortality rates.
How similar studies have performed: Previous studies have shown promising results with similar conditioning approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saint Petersburg
- RM Gorbacheva Research Institute — Saint Petersburg, Russia (RECRUITING)
Study contacts
- Study coordinator: IVAN SERGEEVICH MOISEEV
- Email: moisiv@mail.ru
- Phone: 0079217961951
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Biphenotypic Acute Leukemia, Lymphoblastic Lymphoma, Myeloproliferative Neoplasm, Myelodysplastic Syndromes