Clinical trial · Interventional
Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant
Phase I Trial of Sorafenib Maintenance Therapy for Patients With FLT3-ITD AML After Allogeneic Stem Cell Transplantation
- 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)
Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for patients with AML with the FLT3-ITD mutation and information from these studies suggests that sorafenib may help to control leukemia. The purpose of this study is to find the highest dose of sorafenib for maintenance therapy that can be safely used in participants with AML who have undergone allogeneic stem cell transplant.
Conditions
Conditions (1)
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 | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Post-SCT Sorafenib
- description
- Sorafenib will be given as maintenance therapy after allo HCT to patients with FLT3-ITD AML.
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- 3 years
- description
- To define the maximum tolerated dose (MTD) of maintenance sorafenib after allogeneic HSCT
Secondary outcomes (6)
- measure
- Median number of days sorafenib tolerated
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with AML with the FLT3-ITD mutation who have undergone allogeneic HSCT * Peripheral blood chimerism studies showing \>/= 70% of all cells are of donor origin * Adequate hematologic and hepatic function * ECOG performance status 0-2 * Able to swallow whole pills Exclusion Criteria: * Evidence of relapsed/recurrent/residual disease as assessed by bone marrow aspirate and biopsy performed between days 30-60 after HSCT * Active acute graft vs host disease requiring an equivalent dose of \> 0.5 mg/kg/day of prednisone or equivalent or those patients which necessitated the addition of another agent for the treatment of GVHD beyond corticosteroids * Ongoing uncontrolled infection * Cardiac disease: congestive heart failure \> class II NYHA, unstable angina or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Uncontrolled hypertension * Known HIV infection or chronic hepatitis B or C * Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months * Pulmonary hemorrhage/bleeding event \> CTCAE v 4.0 Grade 2 within 4 weeks of starting study drug * Any other hemorrhage/bleeding event \> CTCAE v. 4.0 Grade 3 within 4 weeks of starting study drug * Serious non-healing wound, non-healing ulcer, or bone fracture * Evidence or history of bleeding diathesis or coagulopathy * Major surgery or significant traumatic injury within 4 weeks of starting study drug * Use of St. John's Wort or rifampin (rifampicin) * Known or suspected allergy to sorafenib * Pregnant or breast-feeding * Receiving any other investigational agents
References
Publications (1)
- RESULTChen YB, Li S, Lane AA, Connolly C, Del Rio C, Valles B, Curtis M, Ballen K, Cutler C, Dey BR, El-Jawahri A, Fathi AT, Ho VT, Joyce A, McAfee S, Rudek M, Rajkhowa T, Verselis S, Antin JH, Spitzer TR, Levis M, Soiffer R. Phase I trial of maintenance sorafenib after allogeneic hematopoietic stem cell transplantation for fms-like tyrosine kinase 3 internal tandem duplication acute myeloid leukemia. Biol Blood Marrow Transplant. 2014 Dec;20(12):2042-8. doi: 10.1016/j.bbmt.2014.09.007. Epub 2014 Sep 17. PMID 25239228