Clinical trial · Interventional
Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen
Randomized Trial of Sorafenib Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplantation Bendamustine and Cyclophosphamide
NCT06532084CI-TRIAL-00079356SoraGVLrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloproliferative Neoplasm | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sorafenib prophylaxis
- description
- Sorafenib 200 mg bid for 168 days starting before day+100 after HCT
- interventionNames
- Drug: Sorafenib
- type
- NO_INTERVENTION
- label
- Observation
- description
- Usual care
Primary outcomes (1)
- measure
- Event-free survival
- timeFrame
- 2 years
- description
- Kaplan-Meier estimate of either relapse or secondary graft failure or death from all causes
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.