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

NCT01358734 | Completed Phase 2 Results DMC

• 1 other identifier: CC-5013-AML-001
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 30

Brief Summary

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).

Conditions

Acute Myeloid Leukemia; Acute Myelogenous Leukemia

Keywords

AML; elderly; acute myelogenous leukemia; vidaza; azacitidine; elderly AML; revlimid; lenalidomide

Outcome Measures

Primary Outcomes (2)

• Kaplan Meier Estimates for One Year Survival

  One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation

  Up to 24 months

• Overall Survival

  Overall Survival reported at the end of the study are for those participants who were alive at the end of the study

  From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)

Secondary Outcomes (10)

• Percentage of Participants With a Complete Response or Morphologic Incomplete Response.

  Complete Response or Morphologic Incomplete Response data not analyzed.

• Duration of Remission (DoR)

  Duration of Remission (DoR) time frame not analyzed.

• Cytogenetic Complete Remission Rate (CRc)

  Cytogenetic Complete Remission timeframe was not analyzed.

• Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)

  Overall response rate time frame was not analyzed.

• Progression-Free Survival (PFS)

  Progression-Free survival data and time frame was not analyzed.

Other Outcomes (1)

• Percentage of Participants Alive at One Year

  Up to 12 months

Study Arms (3)

Lenalidomide in combination with azacitidine

EXPERIMENTAL

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

Drug: Azacitidine; Drug: Lenalidomide; Other: Best Supportive Care (BSC)

Lenalidomide - single agent

EXPERIMENTAL

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

Drug: Lenalidomide; Other: Best Supportive Care (BSC)

Azacitidine-single agent

EXPERIMENTAL

Repeated cycles of azacitidine 75mg/m\^2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care

Drug: Azacitidine; Other: Best Supportive Care (BSC)

Interventions

Azacitidine DRUG

Azacitidine at 75 mg/m\^2/day subcutaneous on Days 1-7

Also known as: Vidaza

Azacitidine-single agent; Lenalidomide in combination with azacitidine

Lenalidomide DRUG

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

Also known as: Revlimid®, CC-5013

Lenalidomide - single agent; Lenalidomide in combination with azacitidine

Best Supportive Care (BSC) OTHER

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; Lenalidomide - single agent; Lenalidomide in combination with azacitidine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• Celgene: lead

Study Sites (30)

(210) University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

(180) University of California, San Diego

La Jolla, California, 92093-0960, United States

Location

(240) Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

(215) Hematology Oncology Medical Group

Orange, California, 92868, United States

Location

(130) UC Davis Medical Center

Sacramento, California, 95857, United States

Location

(200) Coastal Integrative Cancer Care

San Luis Obispo, California, 93401, United States

Location

(125) University of Stanford

Stanford, California, 94305, United States

Location

(115) University of Colorado Anschultz Cancer Center

Aurora, Colorado, 80045, United States

Location

(145) Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

(140) Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

(185) The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

(175) University Lousiville

Louisville, Kentucky, 40202, United States

Location

(195) Tulane University Hospital Tulane Cancer Center

New Orleans, Louisiana, 70072, United States

Location

(235) University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

(100) Washington University School of Medicine

St Louis, Missouri, 63110-1093, United States

Location

(150) Billings Clinic

Billings, Montana, 59101, United States

Location

(165) Mount Sinai Medical Center New York

New York, New York, 10029-65749, United States

Location

(160) The Western Pennsylvania Hospital- Cancer Institute

Pittsburgh, Pennsylvania, 15224-1791, United States

Location

(205) Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

(120) Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

(230) Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

(105) University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center

Dallas, Texas, 75390-9179, United States

Location

(155) Cancer Care Centers of South Texas

San Antonio, Texas, 78229, United States

Location

(135) University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

(402) Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

(405) University of Alberta Hospital

Edmonton, Alberta, T6G 1Z1, Canada

Location

(401) Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

(403) Queen Elizabeth II Health Sciences Centre - VG Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

(404) The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

(400) Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 29097499 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Accrual to the lenalidomide arm was stopped before ending accrual to the 2 other arms because of poor tolerability and no comparison of outcomes was planned.

Results Point of Contact

• Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
• Organization: Celgene Corporation

ClinicalTrialDisclosure@celgene.com

888-260-1599

Study Officials

• Robert Gale, MD

  Celgene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 24, 2011
• Study Start: April 27, 2012
• Primary Completion: May 19, 2015
• Study Completion: May 15, 2018
• Last Updated: June 25, 2019
• Results First Posted: July 4, 2016

Record last verified: 2019-06

Locations

CA (6); US (24)