Lenalidomide as Consolidation and Maintenance in Adults >/= 60 Years of Age With AML Following Standard Induction
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|ClinicalTrials.gov Identifier: NCT01578954|
Recruitment Status : Recruiting
First Posted : April 17, 2012
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Lenalidomide||Phase 1|
This study is a single-arm, open-label phase Ib clinical trial testing the hypothesis that the daily use of lenalidomide will be safe and tolerable as evidenced by the rate of dose-limiting toxicity (DLT) seen during one month of reinduction/consolidation in older (≥ 60 years of age) acute myeloid leukemia (AML) patients treated after one cycle of conventional, anthracycline-based induction. (Re-induction is the prescribed lenalidomide therapy given to patients who are in partial remission/response post induction while consolidation is the same prescribed lenalidomide therapy post induction given to patients who are in complete remission).
Dose escalation will take place within cohorts during the 28-day re-induction/ consolidation lenalidomide treatment at the University of North Carolina at Chapel Hill. After re-induction/consolidation, patients who harbor ≥ 5% peripheral blood or bone marrow myeloblasts will be removed from protocol therapy. Patients who have <5% peripheral blood or bone marrow myeloblasts after consolidation therapy will be allowed to continue to maintenance therapy: lenalidomide 10 mg/day continuously for up to 12 months. Up to 26 patients will be enrolled.
This trial includes a Geriatric Assessment (GA) of each enrolled patient at baseline and serially across the trial. The investigators also plan to study natural killer (NK) cell phenotype and cytolytic function in patients at various intervals across the study (baseline, post re-induction/consolidation, and during maintenance.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LCCC 1111: An Open-Label Dose-Finding Study of Lenalidomide as Reinduction/ Consolidation Followed by Lenalidomide Maintenance Therapy for Adults ≥ 60 Years of Age With Acute Myeloid Leukemia (AML) in Partial or Complete Response Following Conventional Induction Therapy|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2023|
Lenalidomide (25, 35, or 50 mg induction/10mg maintenance)
Reinduction/Consolidation - dose escalation of lenalidomide: Level 1 - 25mg, Level 2 - 35mg, Level 3 - 50mg, PO, QD, 28 days.
Maintenance Lenalidomide - 10mg, PO, QD, continuous dosing, 12 months
Other Name: Revlimid
- Determine the rate of dose limiting toxicities. [ Time Frame: 28 days ]
- Frequency of toxicity [ Time Frame: 28 days ]Number of adverse events that occur during induction/consolidation.
- Duration of toxicity [ Time Frame: 28 days ]Duration is measured by the length of time of a toxicity to resolve or return to baseline that occur during induction.
- Frequency of toxicity [ Time Frame: 12 months ]Frequency will be measured as the number of individual toxicities that occur during maintenance.
- Response rates [ Time Frame: 12 months ]Response is based on the International Working Group to standardize response in AML.
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): NCT01578954
|Contact: Clinical Protocol Office||919-966-4432|
|United States, North Carolina|
|University of North Carolina at Chapel Hill - Lineberger Comprehensive Cancer Center||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Jack Zhang 984-974-8251 firstname.lastname@example.org|
|Principal Investigator: Matthew C Foster, MD|
|Principal Investigator:||Matthew C Foster, MD||UNC Lineberger Comprehensive Cancer Center|