Spots Global Cancer Trial Database for Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
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Trial Identification
Brief Title: Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia
Official Title: A Phase II Study of Lenalidomide (REVLIMID, NSC-703813) for Previously Untreated Non-M3, Deletion 5q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy
Study ID: NCT00352365
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Contact Details
Name: Mikkael Sekeres
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR
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