OncoMatch/Clinical Trials/NCT06532084
Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen
Is NCT06532084 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Sorafenib for acute myeloid leukemia, in relapse.
Treatment: Sorafenib — 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-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Chronic Myeloid Leukemia
Myeloproliferative Neoplasm
Biomarker criteria
Required: TP53 bi-allelic mutation
any myeloid malignancy with bi-allelic tp53 mutation
Required: TP53 bi-allelic mutation
any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression
Required: ASXL1 mutation
any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression
Required: RUNX1 mutation
any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression
Required: MECOM overexpression
any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression
Demographics
Prior therapy
Must have received: allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide (bendamustine, cyclophosphamide) — post-transplant
Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor.
Cannot have received: donor lymphocyte infusion
donor lymphocyte infusion prior to randomization
Cannot have received: any other planned method for prophylaxis of relapse besides sorafenib
use of any other planned method for prophylaxis of relapse besides sorafenib
Lab requirements
Kidney function
creatinine >2 upper normal limits, creatinine clearance < 30 ml/min
Liver function
ast or alt >10 upper normal limits, bilirubin >2 upper normal limits
Cardiac function
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06532084 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior donor lymphocyte infusion, any other planned method for prophylaxis of relapse besides sorafenib disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 bi-allelic mutation is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 bi-allelic mutation is a required biomarker for enrollment.
Does this trial require ASXL1?
Yes, ASXL1 mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify