Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission
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|ClinicalTrials.gov Identifier: NCT02126553|
Recruitment Status : Completed
First Posted : April 30, 2014
Results First Posted : November 14, 2022
Last Update Posted : November 14, 2022
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|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)|
|Actual Enrollment :||29 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|
|Actual Primary Completion Date :||November 30, 2021|
|Actual Study Completion Date :||November 30, 2021|
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 7 Years ]Time from date of treatment start until the date of first objective documentation of disease-relapse.
- Overall Survival (OS) [ Time Frame: Up to 7 Years ]Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.
- Event-free Survival (EFS) [ Time Frame: Up to 7 Years ]Time from date of treatment start until the date of first objective documentation of disease-relapse, death or discontinuation due to adverse events.
- Complete Response (CR) Duration [ Time Frame: Up to 7 years ]Complete Response is defined as disappearance of all clinical and/or radiologic evidence of disease, including extramedullary leukemia. Neutrophil count >/= 1.0 x 10^9/L and platelet count>/= 100 x 10^9, and bone marrow differential showing </=5%blasts. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients aged 18 to 55 years with high risk AML who have achieved their FIRST complete remission (CR) or complete remission with incomplete recovery (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 principal investigator (PI)
- 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, fms-related tyrosine kinase 3 (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 >= 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
- Patients should have received induction chemotherapy for AML and at least 1 consolidation
- Patients with history of extramedullary AML, except for central nervous system (CNS) involvement that is currently controlled, will not be eligible for enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of < or = 3
- Serum total bilirubin < or = to 1.5 X the upper limit of normal (ULN)
- Serum creatinine < or = to 2.5 x ULN
- Absolute neutrophil count (ANC) > 0.5 x 10^9/L
- Platelet count > or = 30 x 10^9/L
- 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 24 hours (hrs) 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
- 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
- All study participants be willing and able to comply with the requirements of the Risk Evaluation and Mitigation Strategies (REMS) program
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
- Ability to understand and sign informed consent
- Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by French American British (FAB) classification based on morphology, immunophenotype, molecular, or cytogenetics studies
- Diagnosis of AML associated with the following karyotypes: inversion (inv)(16), t(16;16), t(8;21), t(15;17), or t(9;22)
- 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
- Previous treatment with lenalidomide for AML
- Patients with documented hypersensitivity to any components of the study program
- Females who are pregnant
- Patients with active CNS disease
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
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Tapan M Kadia||M.D. Anderson Cancer Center|
Documents provided by M.D. Anderson Cancer Center:
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
NCI-2014-01176 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0116 ( Other Identifier: M D Anderson Cancer Center )
|First Posted:||April 30, 2014 Key Record Dates|
|Results First Posted:||November 14, 2022|
|Last Update Posted:||November 14, 2022|
|Last Verified:||October 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Physiological Effects of Drugs
Angiogenesis Modulating Agents