Clinical Trials /

Lenalidomide Maintenance With High Risk (HR) Acute Myeloid Leukemia (AML) in Remission

NCT02126553

Description:

The goal of this clinical research study is learn if Revlimid® (lenalidomide) can help to keep acute myeloid leukemia (AML) patients in remission. The safety of this drug will also be studied. 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 50 participants will be enrolled in this multicenter study. All will take part at MD Anderson.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Lenalidomide Maintenance With High Risk (HR) Acute Myeloid Leukemia (AML) in Remission
  • Official Title: Phase II Study of Lenalidomide Maintenance in Patients With High Risk Acute Myeloid Leukemia (AML) in Remission

Clinical Trial IDs

  • ORG STUDY ID: 2014-0116
  • SECONDARY ID: NCI-2014-01176
  • NCT ID: NCT02126553

Conditions

  • Leukemia

Interventions

DrugSynonymsArms
LenalidomideCC-5013, RevlimidLenalidomide

Purpose

The goal of this clinical research study is learn if Revlimid® (lenalidomide) can help to keep acute myeloid leukemia (AML) patients in remission. The safety of this drug will also be studied. 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 50 participants will be enrolled in this multicenter study. All will take part at MD Anderson.

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.
    

Trial Arms

NameTypeDescriptionInterventions
LenalidomideExperimentalLenalidomide starting dose: 10 mg by mouth on days 1- 28 of a 28 day cycle. If after one cycle, the patient has persistent evidence of (1) minimal residual disease or (2) morphologically active disease AND is tolerating their starting dose of lenalidomide, their dose may be increased to the next higher dose level for the remainder of the study. A maximum of 2 dose escalations per patient are allowed if well tolerated.
  • Lenalidomide

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Relapse-Free Survival (RFS) With Lenalidomide Maintenance Therapy
Time Frame:28 days
Safety Issue:
Description:Relapse-free survival (RFS), defined as the time interval from date of treatment start until the date of death or disease relapse. Response Criteria based on the Revised Recommendations of the International Working Group Response Criteria in Acute Myeloid Leukemia. Study continuously monitored for the primary endpoint, RFS, using the method of Thall, Wooten, and Tannir (2005).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Leukemia
  • Acute myeloid leukemia
  • AML
  • Remission
  • Lenalidomide
  • CC-5013
  • Revlimid

Last Updated