Lenalidomide Maintenance With High Risk (HR) Acute Myeloid Leukemia (AML) in Remission
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02126553|
Recruitment Status : Recruiting
First Posted : April 30, 2014
Last Update Posted : May 27, 2019
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|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Starting dose: 10 mg by mouth on days 1- 28 of a 28 day cycle.
- 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).
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
|Contact: Tapan Kadia, MDfirstname.lastname@example.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Tapan Kadia, MD||M.D. Anderson Cancer Center|