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A Phase 2, Multicenter, Randomized, Open-label, Parallel-group Study of a Lenalidomide (Revlimid®) Regimen or a Sequential Azacitidine (Vidaza®) Plus Lenalidomide (Revlimid®) Regimen Versus an Azacitidine (Vidaza®) Regimen for Therapy of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia


Phase 2
65 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia, Acute Myelogenous Leukemia

Thank you

Trial Information

A Phase 2, Multicenter, Randomized, Open-label, Parallel-group Study of a Lenalidomide (Revlimid®) Regimen or a Sequential Azacitidine (Vidaza®) Plus Lenalidomide (Revlimid®) Regimen Versus an Azacitidine (Vidaza®) Regimen for Therapy of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia


Inclusion Criteria:



- Newly diagnosed acute myelogenous leukemia (AML), in elderly patients, AML with
antecedent hematologic disorder, or therapy-related AML

- Elderly 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 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

- White blood cell (WBC) count > 10 x 10⁹/L at screening

- Presence of malignant disease within the previous 12 months with exceptions.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Elderly Subjects Alive

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

CL Beach, PharmD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-AML-001

NCT ID:

NCT01358734

Start Date:

August 2011

Completion Date:

June 2017

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myelogenous Leukemia
  • AML
  • elderly
  • acute myelogenous leukemia
  • vidaza
  • azacitidine
  • elderly AML
  • revlimid
  • lenalidomide
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location
(210) University of Arizona Cancer Center Tucson, Arizona  85724
(200) Coastal Integrative Cancer Care San Luis Obispo, California  93401
(125) University of Stanford Stanford, California  94305
(115) University of Colorado Anschultz Cancer Center Aurora, Colorado  80045
(145) Mount Sinai Comprehensive Cancer Center Miami Beach, Florida  33140
(195) Tulane University Hospital Tulane Cancer Center New Orleans, Louisiana  70072
(100) Washington University School of Medicine St. Louis, Missouri  63110-1093
(150) Billings Clinic Billings, Montana  59101
(160) The Western Pennsylvania Hospital- Cancer Institute Pittsburgh, Pennsylvania  15224-1791
(205) Greenville Hospital System Greenville, South Carolina  29605
(120) Avera Cancer Institute Sioux Falls, South Dakota  57105
(105) University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center Dallas, Texas  75390-9179
(180) University of California, San Diego La Jolla, California  92093-0960
(240) Cedars-Sinai Medical Center Los Angeles, California  90048
(215) Hematology Oncology Medical Group Orange, California  92868
(130) UC Davis Medical Center Sacramento, California  95857
(140) Rush University Medical Center Chicago, Illinois  60612
(185) The University of Kansas Cancer Center Westwood, Kansas  66205
(175) University Lousiville Louisville, Kentucky  40202
(235) University of Minnesota Minneapolis, Minnesota  55455
(165) Mount Sinai Medical Center New York New York, New York  10029-65749
(230) Tennessee Oncology, PLLC Nashville, Tennessee  37203
(155) Cancer Care Centers of South Texas San Antonio, Texas  78229
(135) University of Wisconsin Madison, Wisconsin  53792