Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

NCT ID: NCT00352365

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2011-07-01

Brief Summary

This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

Detailed Description

PRIMARY OBJECTIVES:

I. Test whether the complete response rate among older patients with previously untreated acute myeloid leukemia (AML) with the del (5q) cytogenetic abnormality treated with lenalidomide is sufficiently high to warrant a phase III investigation.

II. Estimate the frequency and severity of toxicities of this drug in these patients.

III. Correlate, in a preliminary manner, additional cytogenetic abnormalities with response to lenalidomide.

IV. Estimate the total (complete and partial) response rate and the cytogenetic response rate in these patients.

OUTLINE:

INDUCTION THERAPY: Patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy.

MAINTENANCE THERAPY: Beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

Conditions

Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (lenalidomide)

INDUCTION THERAPY: Patients receive oral lenalidomide once daily on days 1-14, 1-21, or 1-28 (course 1). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy.

MAINTENANCE THERAPY: Beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

lenalidomide

Intervention Type: DRUG

Given orally

Interventions

lenalidomide

Given orally

Intervention Type: DRUG

Other Intervention Names

CC-5013; IMiD-1; Revlimid

Eligibility Criteria

Inclusion Criteria

• Morphologically confirmed diagnosis of acute myeloid leukemia (AML) by bone marrow aspiration and biopsy within the past 14 days

• Diagnostic biopsy within the past 28 days with marrow blast percentage ≥ 70% allowed provided no potentially antileukemic therapy was received after biopsy
• Cytogenetic evidence of del (5q) abnormality by conventional karyotyping or fluorescence in situ hybridization (FISH)
• Previously untreated disease

• Must have declined standard AML cytotoxic chemotherapy regimens
• WBC ≤ 30,000/mm³
• History of prior myelodysplastic syndromes (MDS) allowed
• No acute promyelocytic leukemia (FAB M3)
• No blastic transformation of chronic myelogenous leukemia
• Zubrod performance status 0-2
• Bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, but not to liver dysfunction)
• AST and ALT ≤ 3.5 times ULN
• Creatinine ≤ 1.5 times ULN
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use 2 forms of effective contraception at least 4 weeks prior to, during, and for 4 weeks after completion of study treatment
• No known allergy to thalidomide
• Concurrent enrollment on SWOG-S9910 allowed (for SWOG patients)
• No prior systemic chemotherapy for acute leukemia except hydroxyurea

• Single-dose intrathecal chemotherapy allowed before or concurrently with induction chemotherapy
• No prior AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support
• Prior hematopoietic growth factors, thalidomide, arsenic trioxide, signal-transduction inhibitors, azacitidine, and low-dose cytarabine (i.e., < 100 mg/m²/day) for treatment of MDS allowed
• At least 30 days since prior therapy for MDS (excluding growth factors)
• No prior lenalidomide for MDS
• At least 6 months since prior chemotherapy or radiotherapy for another malignancy
• No concurrent therapy for another malignancy
• Concurrent hormonal therapy allowed

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikkael Sekeres

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Shasta Regional Medical Center

Redding, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sutter General Hospital

Sacramento, California, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Cancer Care Center of Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Salina Regional Health Center

Salina, Kansas, United States

University of Michigan

Ann Arbor, Michigan, United States

Montana Cancer Consortium CCOP

Billings, Montana, United States

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

Saint Vincent Healthcare

Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies PC

Billings, Montana, United States

Billings Clinic

Billings, Montana, United States

Deaconess Medical Center

Billings, Montana, United States

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Berdeaux, Donald MD (UIA Investigator)

Great Falls, Montana, United States

Great Falls Clinic

Great Falls, Montana, United States

Northern Montana Hospital

Havre, Montana, United States

Saint Peter's Community Hospital

Helena, Montana, United States

Glacier Oncology PLLC

Kalispell, Montana, United States

Kalispell Medical Oncology

Kalispell, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Community Medical Hospital

Missoula, Montana, United States

Montana Cancer Specialists

Missoula, Montana, United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Interlakes Foundation Inc-Rochester

Rochester, New York, United States

University of Rochester

Rochester, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic Cancer Center Independence

Independence, Ohio, United States

Cleveland Clinic Wooster Specialty Center

Wooster, Ohio, United States

University of Tennessee - Knoxville

Knoxville, Tennessee, United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Harrison Bremerton Hematology and Oncology

Bremerton, Washington, United States

Columbia Basin Hematology and Oncology PLLC

Kennewick, Washington, United States

Skagit Valley Hospital

Mount Vernon, Washington, United States

Harrison Poulsbo Hematology and Oncology

Poulsbo, Washington, United States

Harborview Medical Center

Seattle, Washington, United States

Minor and James Medical PLLC

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Group Health Cooperative

Seattle, Washington, United States

Swedish Medical Center-First Hill

Seattle, Washington, United States

The Polyclinic

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

United General Hospital

Sedro-Woolley, Washington, United States

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Evergreen Hematology and Oncology PS

Spokane, Washington, United States

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Rocky Mountain Oncology

Casper, Wyoming, United States

Welch Cancer Center

Sheridan, Wyoming, United States

Countries

United States

References

Sekeres MA, Gundacker H, Lancet J, Advani A, Petersdorf S, Liesveld J, Mulford D, Norwood T, Willman CL, Appelbaum FR, List AF. A phase 2 study of lenalidomide monotherapy in patients with deletion 5q acute myeloid leukemia: Southwest Oncology Group Study S0605. Blood. 2011 Jul 21;118(3):523-8. doi: 10.1182/blood-2011-02-337303. Epub 2011 May 6.

Reference Type: DERIVED

PMID: 21551228 (View on PubMed)

Other Identifiers

NCI-2009-00785

Identifier Type: REGISTRY

Identifier Source: secondary_id

SWOG-S0605

Identifier Type: -

Identifier Source: secondary_id

CDR0000484449

Identifier Type: -

Identifier Source: secondary_id

S0605

Identifier Type: OTHER

Identifier Source: secondary_id

S0605

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00785

Identifier Type: -

Identifier Source: org_study_id