Status:
RECRUITING
Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Acute Myeloid Leukemia, in Relapse
Myelodysplastic Syndromes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantatio...
Detailed Description
Allogeneic hematopoietic stem cell transplantation (HCT) results steadily improve due to reduction of NRM. Standard risk patients now have the risk of HCT below 10% after matched donor transplantation...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06532084
Start Date
May 22 2024
End Date
May 1 2028
Last Update
August 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
RM Gorbacheva Research Institute
Saint Petersburg, Russia, 197022