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

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia, Acute Myelogenous Leukemia

In brief

The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).

Key facts

Study ID: NCT01358734
Run by: Celgene
People needed: 88
Starts: 2012-04-27
Expected to finish: 2018-05-15
Last updated by the study team: 2019-06-25

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML
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

You may not qualify if…

Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
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

Where it is running

(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

Full record on ClinicalTrials.gov

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