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Phase I Trial of Sorafenib Maintenance Therapy for Patients With FLT3-ITD AML After Allogeneic Stem Cell Transplantation

Phase 1
18 Years
75 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

Phase I Trial of Sorafenib Maintenance Therapy for Patients With FLT3-ITD AML After Allogeneic Stem Cell Transplantation

Subjects will taken sorafenib orally either once or twice daily. Subjects will come to the
Bone Marrow Transplant Clinic 3 times (on Day 8, 15, and 30) during the first month of
treatment. After the first month, they will be seen every month for 3 months and then at 9
at 6 and 9 months. Subjects will have a physical exam and be asked questions regarding
general health and specific questions about any problems they might be having and any
medications they are taking.

Subjects will have standard blood tests every month for 12 months to check liver and kidney
function and complete blood count.

Subjects will have research blood tests on Days 8, 15 and 30 during the first month of

Subjects will have a bone marrow biopsy after 3 months and 12 months of treatment.

Subjects will receive treatment for up to 12 months and be followed for 1 year after
completing the study.

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

To define the maximum tolerated dose (MTD) of maintenance sorafenib after allogeneic HSCT

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Yi-Bin Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

August 2011

Completion Date:

August 2016

Related Keywords:

  • Acute Myeloid Leukemia
  • AML
  • FLT3-ITD
  • Stem cell transplant
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617