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Trial record 13 of 878 for:    LENALIDOMIDE

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

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ClinicalTrials.gov Identifier: NCT02126553
Recruitment Status : Recruiting
First Posted : April 30, 2014
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Leukemia Drug: Lenalidomide Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Lenalidomide Maintenance in Patients With High Risk Acute Myeloid Leukemia (AML) in Remission
Actual Study Start Date : November 2014
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2023


Arm Intervention/treatment
Experimental: Lenalidomide
Lenalidomide 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.
Drug: Lenalidomide
Starting dose: 10 mg by mouth on days 1- 28 of a 28 day cycle.
Other Names:
  • CC-5013
  • Revlimid




Primary Outcome Measures :
  1. Relapse-Free Survival (RFS) With Lenalidomide Maintenance Therapy [ Time Frame: 28 days ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126553


Contacts
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Contact: Tapan Kadia, MD 713-563-3534 tkadia@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene
Investigators
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Principal Investigator: Tapan Kadia, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02126553     History of Changes
Other Study ID Numbers: 2014-0116
NCI-2014-01176 ( Registry Identifier: NCI CTRP )
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Acute myeloid leukemia
AML
Remission
Lenalidomide
CC-5013
Revlimid

Additional relevant MeSH terms:
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Lenalidomide
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents