Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission

NCT02126553 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2014-0116NCI-2014-01176
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Alkylating Agent-Related Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Relapse-free Survival (RFS)

  Time from date of treatment start until the date of first objective documentation of disease-relapse.

  Up to 7 Years

Secondary Outcomes (3)

• Overall Survival (OS)

  Up to 7 Years

• Event-free Survival (EFS)

  Up to 7 Years

• Complete Response (CR) Duration

  Up to 7 years

Study Arms (1)

Treatment (lenalidomide)

EXPERIMENTAL

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; Drug: Lenalidomide

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (lenalidomide)

Lenalidomide DRUG

Given PO

Also known as: CC-5013, CC5013, CDC 501, Revlimid

Treatment (lenalidomide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Tapan Kadia MD./Professor
• Organization: The University of Texas MD Anderson Cancer Center

tkadia@mdanderson.org

713-563-3534

Study Officials

• Tapan M Kadia

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: November 13, 2014
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Locations

US (1)