Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant

Mass General Brigham

Status and phase

Completed

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Sorafenib

Study type

Interventional

Funder types

Other

Identifiers

NCT01398501

11-114

Details and patient eligibility

About

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.

Full description

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 treatment.

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.

Enrollment

22 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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