A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia
NCT ID: NCT01358734
Last Updated: 2019-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2012-04-27
2018-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lenalidomide in combination with azacitidine
Repeated cycles of azacitidine 75 mg/m\^2/day subcutaneous (SC) on Days 1-7 and lenalidomide 50 mg/day by mouth (PO) on Days 8-28 followed by a 14-day break plus best supportive care
Azacitidine
Azacitidine at 75 mg/m\^2/day subcutaneous on Days 1-7
Lenalidomide
Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
Best Supportive Care (BSC)
The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.
BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Lenalidomide - single agent
Lenalidomide 50 mg PO daily for 28 days for the first 2 cycles and lenalidomide 25 mg daily for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg daily PO plus best supportive care
Lenalidomide
Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
Best Supportive Care (BSC)
The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.
BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Azacitidine-single agent
Repeated cycles of azacitidine 75mg/m\^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care
Azacitidine
Azacitidine at 75 mg/m\^2/day subcutaneous on Days 1-7
Best Supportive Care (BSC)
The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.
BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Interventions
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Azacitidine
Azacitidine at 75 mg/m\^2/day subcutaneous on Days 1-7
Lenalidomide
Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
Best Supportive Care (BSC)
The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.
BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female subjects aged ≥ 65
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* White blood cell (WBC) count ≤ 10 x 10⁹/L at screening
Exclusion Criteria
* Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents.
* Suspected or proven acute promyelocytic leukemia
* Prior bone marrow or stem cell transplantation
* Candidate for allogeneic bone marrow or stem cell transplantation
* AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
* Presence of malignant disease within the previous 12 months with exceptions
65 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Gale, MD
Role: STUDY_DIRECTOR
Celgene
Locations
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(210) University of Arizona Cancer Center
Tucson, Arizona, United States
(180) University of California, San Diego
La Jolla, California, United States
(240) Cedars-Sinai Medical Center
Los Angeles, California, United States
(215) Hematology Oncology Medical Group
Orange, California, United States
(130) UC Davis Medical Center
Sacramento, California, United States
(200) Coastal Integrative Cancer Care
San Luis Obispo, California, United States
(125) University of Stanford
Stanford, California, United States
(115) University of Colorado Anschultz Cancer Center
Aurora, Colorado, United States
(145) Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
(140) Rush University Medical Center
Chicago, Illinois, United States
(185) The University of Kansas Cancer Center
Westwood, Kansas, United States
(175) University Lousiville
Louisville, Kentucky, United States
(195) Tulane University Hospital Tulane Cancer Center
New Orleans, Louisiana, United States
(235) University of Minnesota
Minneapolis, Minnesota, United States
(100) Washington University School of Medicine
St Louis, Missouri, United States
(150) Billings Clinic
Billings, Montana, United States
(165) Mount Sinai Medical Center New York
New York, New York, United States
(160) The Western Pennsylvania Hospital- Cancer Institute
Pittsburgh, Pennsylvania, United States
(205) Greenville Hospital System
Greenville, South Carolina, United States
(120) Avera Cancer Institute
Sioux Falls, South Dakota, United States
(230) Tennessee Oncology, PLLC
Nashville, Tennessee, United States
(105) University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
Dallas, Texas, United States
(155) Cancer Care Centers of South Texas
San Antonio, Texas, United States
(135) University of Wisconsin
Madison, Wisconsin, United States
(402) Tom Baker Cancer Centre
Calgary, Alberta, Canada
(405) University of Alberta Hospital
Edmonton, Alberta, Canada
(401) Cancer Care Manitoba
Winnipeg, Manitoba, Canada
(403) Queen Elizabeth II Health Sciences Centre - VG Site
Halifax, Nova Scotia, Canada
(404) The Ottawa Hospital
Ottawa, Ontario, Canada
(400) Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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References
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Medeiros BC, McCaul K, Kambhampati S, Pollyea DA, Kumar R, Silverman LR, Kew A, Saini L, Beach CL, Vij R, Wang X, Zhong J, Gale RP. Randomized study of continuous high-dose lenalidomide, sequential azacitidine and lenalidomide, or azacitidine in persons 65 years and over with newly-diagnosed acute myeloid leukemia. Haematologica. 2018 Jan;103(1):101-106. doi: 10.3324/haematol.2017.172353. Epub 2017 Nov 2.
Other Identifiers
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CC-5013-AML-001
Identifier Type: -
Identifier Source: org_study_id
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