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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 : September 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase II trial studies how well lenalidomide works in treating patients with acute myeloid leukemia that have had a decrease in or disappearance of signs and symptoms of cancer, although cancer still may be in the body and may be likely to come back or spread. Biological therapies, such as lenalidomide, use substances made from living organisms that may kill cancer cells by blocking blood flow to the cancer and by stimulating white blood cells to kill the cancer cells.

Condition or disease Intervention/treatment Phase
Alkylating Agent-Related Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia Other: Laboratory Biomarker Analysis Drug: Lenalidomide Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. To assess relapse-free survival (RFS) of patients with acute myeloid leukemia (AML) treated with lenalidomide maintenance therapy after achieving remission.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.


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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 AML in Remission
Actual Study Start Date : November 13, 2014
Estimated Primary Completion Date : November 1, 2022


Arm Intervention/treatment
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
Correlative studies

Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid




Primary Outcome Measures :
  1. Relapse-free survival (RFS) [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 12 months ]
  2. Event-free survival (EFS) [ Time Frame: Up to 12 months ]
  3. Complete response (CR) duration [ Time Frame: Up to 12 months ]
  4. Incidence of toxicities associated with lenalidomide [ Time Frame: Up to 12 months ]
    Toxicity and tolerability of the regimen will be determined.

  5. Natural killer (NK) cell biology [ Time Frame: Up to 12 months ]
    The effect of lenalidomide maintenance on NK cell biology will be determined.

  6. 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.



Information from the National Library of Medicine

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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:

  • 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

Exclusion Criteria:

  • 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

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
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Tapan M. Kadia    713-563-3534      
Principal Investigator: Tapan M. Kadia         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Tapan M Kadia 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: CTRP (Clinical Trial Reporting Program) )
2014-0116 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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