Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen

Launched by ST. PETERSBURG STATE PAVLOV MEDICAL UNIVERSITY · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called sorafenib to see if it can help prevent the return of certain serious blood cancers, like acute myeloid leukemia and myelodysplastic syndromes, after patients receive a specific type of stem cell transplant. The study is for adults aged 18 to 74 who have been identified as at high risk for their cancer returning and are undergoing an allogeneic hematopoietic stem cell transplant, which is a procedure that uses stem cells from a donor to help rebuild the patient's blood system. Participants will be randomly assigned to either receive sorafenib or just be monitored without additional treatment.

To join the study, patients need to be in a certain stage of their cancer treatment and have had a successful stem cell transplant. They should also be in remission, meaning their cancer is not currently detectable in the bone marrow. Participants will be closely watched for any side effects and how well the treatment works over the first 100 days after their transplant. It's important for potential participants to know that there are specific health conditions that might prevent them from joining, such as severe heart or lung problems, ongoing infections, or certain recent medical issues. This trial is currently recruiting participants who meet the eligibility criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor.
• * Patients must have high-risk myeloid malignancy as an indication for transplantation defined as:
• • acute myeloid leukemia not in hematological remission prior to transplantation,
• • ≥ 3 remission of acute myeloid leukemia,
• • any myeloid malignancy with bi-allelic tp53 mutation,
• • any myeloid malignancy with complex karyotype,
• • therapy-related myeloid malignancy not in MRD-negative response
• • myelodysplastic syndrome with very high IPSS-R risk
• • any myeloid malignancy with monosomal or t(3;3) karyotype,
• • any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression
• • MDS/NPM unclassified not in hematologic remission.
• • Documented hematological remission in the bone marrow at the time of inclusion post-engraftment, measurable residual disease is allowed
• • First 100 days after allogeneic hematopoietic stem cell transplantation
• Exclusion Criteria:
• • successfully treated relapse between transplantation and enrollment
• • use of any other planned method for prophylaxis of relapse besides sorafenib
• • donor lymphocyte infusion prior to randomization
• • Second malignancy not in complete remission within 6 months prior to randomization
• • 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 \>10 upper normal limits, bilirubin \>2 upper normal limits, creatinine \>2 upper normal limits
• • Creatinine clearance \< 30 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
• • Requirement for positive-pressure oxygen at the time of enrollment
• • Karnofsky index \<30%
• • Pregnancy
• • Somatic or psychiatric disorder making the patient unable to sign informed consent