Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission
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|ClinicalTrials.gov Identifier: NCT02126553|
Recruitment Status : Recruiting
First Posted : April 30, 2014
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alkylating Agent-Related Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia||Other: Laboratory Biomarker Analysis Drug: Lenalidomide||Phase 2|
I. To assess relapse-free survival (RFS) of patients with acute myeloid leukemia (AML) treated with lenalidomide maintenance therapy after achieving remission.
I. To assess overall survival (OS) of patients with AML treated with lenalidomide maintenance.
II. To assess event-free survival (EFS) of patients with AML treated with lenalidomide maintenance.
III. To assess the duration of remission (CRd) of patients with AML treated with lenalidomide maintenance.
IV. To assess toxicity and safety of lenalidomide maintenance in patients with AML.
V. To assess the effects of lenalidomide maintenance on natural killer (NK) cell modulation and dynamics of minimal residual disease and their relationship to outcomes.
Patients receive lenalidomide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6-12 months.
|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 AML in Remission|
|Actual Study Start Date :||November 13, 2014|
|Estimated Primary Completion Date :||November 1, 2022|
Experimental: Treatment (lenalidomide)
Patients receive lenalidomide PO QD on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Relapse-free survival (RFS) [ Time Frame: Up to 12 months ]
- Overall survival (OS) [ Time Frame: Up to 12 months ]
- Event-free survival (EFS) [ Time Frame: Up to 12 months ]
- Complete response (CR) duration [ Time Frame: Up to 12 months ]
- Incidence of toxicities associated with lenalidomide [ Time Frame: Up to 12 months ]Toxicity and tolerability of the regimen will be determined.
- Natural killer (NK) cell biology [ Time Frame: Up to 12 months ]The effect of lenalidomide maintenance on NK cell biology will be determined.
- Dynamics of minimal residual disease [ Time Frame: Up to 12 months ]The effect of lenalidomide maintenance on the dynamics of minimal residual disease will be determined.
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|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Tapan M. Kadia 713-563-3534|
|Principal Investigator: Tapan M. Kadia|
|Principal Investigator:||Tapan M Kadia||M.D. Anderson Cancer Center|