Lenalidomide Maintenance With High Risk (HR) Acute Myeloid Leukemia (AML) in Remission
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Leukemia, Acute myeloid leukemia, AML, Remission, Lenalidomide, CC-5013, Revlimid
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Lenalidomide
Type: Drug
Overall Status
The goal of this clinical research study is learn if Revlimid® (lenalidomide) can help to keep AML patients in remission. The safety of this drug will also be studied.
Detailed Description
Study Drug Administration:

If you are found to be eligible to take part in this study, you will take lenalidomide by mouth with water 1 time a day during each 28-day cycle. If your doctor thinks it is needed, the amount of lenalidomide you take while on study may be increased.

Study Visits:

Every month for the first 3 months, then every 3 months until Month 12, then every 6 months after that, you will have a physical exam.

Blood (about 2-3 teaspoons) will be drawn for routine tests 1-2 times every week during Cycle 1, then every 2-4 weeks during Cycles 2-6, then every 4 weeks after that.

After cycle 1, after 3 months of therapy, then every 3 months until Cycle 12, and then every 6 months after that, you will have a bone marrow aspiration/biopsy to check the status of the disease. This may be performed at other times if your doctor thinks it is needed.

As part of the study, you will be enrolled on a special program called REMS that will inform you about the risks of lenalidomide and pregnancy. As part of this program, you will be required to have regular pregnancy tests if you are a female who is able to have children.

Length of Treatment:

You may continue taking the study drug for up to 24 cycles as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Lenalidomide is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS) and multiple myeloma (MM). Its use in patients with high risk AML that is in remission is investigational.

Up to 80 participants will be enrolled in this multicenter study. All will take part at MD Anderson.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Patients aged 18 to 55 years with high risk (as defined in #2) AML who have achieved their FIRST CR or CRi within 12 months of enrollment and are not immediately candidates for allogeneic stem cell transplant. Patients above age 55 who are not eligible for other protocols may be considered for enrollment on a case by case basis after discussion with the PI.

2. 2. Patients in their FIRST CR or CRi may be eligible for enrollment only if they have a high risk feature, including, but not limited to: adverse karyotype, FLT3 mutation, history of antecedent hematologic disorder (AHD), presence of dysplasia in the bone marrow, therapy-related AML, history of requiring more than 1 cycle of intensive induction chemotherapy to achieve first remission, or presence of persistent minimal residual disease (detected by cytogenetics, molecular markers, or flow cytometry) at any point after initial induction cycle. Patients aged > or = 18 years with AML who have achieved a SECOND CR or CRi within 12 months of enrollment and are not immediately candidates for allogeneic stem cell transplant are also eligible.

3. Patients should have received induction chemotherapy for AML and at least 1 consolidation.

4. Patients with history of extramedullary AML, except for CNS involvement that is currently controlled, will not be eligible for enrollment.

5. ECOG performance status of < or = 3

6. Adequate organ function as follows: a. Serum total bilirubin < or = to 1.5 X the Upper Limit of Normal (ULN) b. Serum creatinine < or = to 2.5 x ULN

7. Adequate BM reserve: a. Absolute neutrophil count (ANC) > 0.5 x 109/L b. Platelet count > or = 30 x 109/L

8. For females of childbearing age, they may participate it they: a. Have a negative serum or urine pregnancy test within 10 to 14 days of enrolling (A second pregnancy test will be performed within 24hrs of starting therapy and both negative pregnancy tests will be required for starting therapy.) b. Agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 28 days after discontinuing treatment.

9. For male patients with a female partner of childbearing age, they may participate if they agree to either abstinence or 2 effective contraceptive methods throughout the treatment period and up to 28 days after discontinuing treatment.

10. All study participants be willing and able to comply with the requirements of the REMS® program.

11. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.

12. Ability to understand and sign informed consent.

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by FAB classification based on morphology, immunophenotype, molecular, or cytogenetic s studies.

2. Diagnosis of AML associated with the following karyotypes: inv(16), t(16;16), t(8;21), t(15;17), or t(9;22)

3. Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

4. Previous treatment with lenalidomide for AML.

5. Patients with documented hypersensitivity to any components of the study program.

6. Females who are pregnant.

7. Patients with active CNS disease.
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
November 2014
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page