Clinical trial · Interventional
Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia
Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allogeneic Hematopoietic Stem Cell Transplant Recipients With FLT3 Negative Acute Leukemia
NCT04674345CI-TRIAL-00054920unknownPhase 2 / Phase 3ClinicalTrials.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)
The purpose of this study is to evaluate the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients.
Conditions
Conditions (3)
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 Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Relapse | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sorafenib group
- description
- Sorafenib will be administered at 45-60 days post-transplantation and taken for one year.
- interventionNames
- Drug: Sorafenib
- type
- NO_INTERVENTION
- label
- Non-maintenance group
- description
- Neither sorafenib nor other FLT3 inhibitors will be used, unless the patient experiences relapse.
Primary outcomes (1)
- measure
- Incidence of leukemia relapse
- timeFrame
- 1 year
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with FLT3-negative acute leukemia undergoing first allo-HSCT * Age 18 to 65 years old with ECOG performance status 0-2 * Hematopoietic recovery within 60 days post-transplantation * Sign informed consent form, have the ability to comply with study and follow-up procedures Exclusion Criteria: * Acute promyelocytic leukemia (AML subtype M3) * Acute leukemia with FLT3-ITD or FLT3-TKD mutations * Philadelphia-positive acute lymphoblastic leukemia * Chronic myelogenous leukemia with blast crisis * Intolerance to sorafenib pre-transplantation * Life expectancy less than 30 days post-transplantation * Active aGVHD or uncontrolled infections within 60 days post-transplantation * Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy) * Respiratory failure ( PaO2 ≤60mmHg) * Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase \>2 times the upper limit of normal) * Renal dysfunction (creatinine clearance rate \< 30 mL/min) * ECOG performance status 3, 4 or 5 * With any conditions not suitable for the trial (investigators' decision)
References
Publications (0)
Data not yet available
No reference posted for this study.