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
1 other identifier
interventional
22
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2011
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedMarch 22, 2017
March 1, 2017
4.1 years
July 19, 2011
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose
To define the maximum tolerated dose (MTD) of maintenance sorafenib after allogeneic HSCT
3 years
Secondary Outcomes (6)
Median number of days sorafenib tolerated
3 years
Rate of serious infections
3 years
Rate of acute GVHD
3 years
Rate of chronic GVHD
3 years
Survival
3 years
- +1 more secondary outcomes
Study Arms (1)
Post-SCT Sorafenib
EXPERIMENTALSorafenib will be given as maintenance therapy after allo HCT to patients with FLT3-ITD AML.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Dana-Farber Cancer Institutecollaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02214, United States
Related Publications (1)
Chen 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: 25239228RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Bin Chen, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
July 19, 2011
First Posted
July 20, 2011
Study Start
August 1, 2011
Primary Completion
September 1, 2015
Study Completion
August 1, 2016
Last Updated
March 22, 2017
Record last verified: 2017-03