Acute Myeloid Leukemia Clinical Trial

Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT00352365

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 43 Locations for this study

See Locations Near You

University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Shasta Regional Medical Center
Redding California, 96001, United States
Sutter Roseville Medical Center
Roseville California, 95661, United States
Sutter General Hospital
Sacramento California, 95816, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Cancer Care Center of Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Salina Regional Health Center
Salina Kansas, 67401, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Montana Cancer Consortium CCOP
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
Saint Vincent Healthcare
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies PC
Billings Montana, 59102, United States
Billings Clinic
Billings Montana, 59107, United States
Deaconess Medical Center
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte Montana, 59701, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls Montana, 59405, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
Northern Montana Hospital
Havre Montana, 59501, United States
Saint Peter's Community Hospital
Helena Montana, 59601, United States
Glacier Oncology PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Hospital
Missoula Montana, 59801, United States
Montana Cancer Specialists
Missoula Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula Montana, 59802, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Interlakes Foundation Inc-Rochester
Rochester New York, 14623, United States
University of Rochester
Rochester New York, 14642, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Cleveland Clinic Cancer Center Independence
Independence Ohio, 44131, United States
Cleveland Clinic Wooster Specialty Center
Wooster Ohio, 44691, United States
University of Tennessee - Knoxville
Knoxville Tennessee, 37920, United States
PeaceHealth Saint Joseph Medical Center
Bellingham Washington, 98225, United States
Harrison Bremerton Hematology and Oncology
Bremerton Washington, 98310, United States
Columbia Basin Hematology and Oncology PLLC
Kennewick Washington, 99336, United States
Skagit Valley Hospital
Mount Vernon Washington, 98274, United States
Harrison Poulsbo Hematology and Oncology
Poulsbo Washington, 98370, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Minor and James Medical PLLC
Seattle Washington, 98104, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle Washington, 98109, United States
Group Health Cooperative
Seattle Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle Washington, 98122, United States
The Polyclinic
Seattle Washington, 98122, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
United General Hospital
Sedro-Woolley Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane Washington, 99218, United States
Wenatchee Valley Medical Center
Wenatchee Washington, 98801, United States
Rocky Mountain Oncology
Casper Wyoming, 82609, United States
Welch Cancer Center
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

41

Study ID:

NCT00352365

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider