Clinical trial NCT01358734: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Acute Myelogenous Leukemia
Keywords: AML
elderly
acute myelogenous leukemia
vidaza
azacitidine
elderly AML
revlimid
lenalidomide
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 88
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.

Eligibility criteria: Inclusion Criteria:

* 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

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
* AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
* Presence of malignant disease within the previous 12 months with exceptions

Primary outcomes:
measure: Kaplan Meier Estimates for One Year Survival
timeFrame: Up to 24 months
measure: Overall Survival
timeFrame: 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:
measure: Percentage of Participants With a Complete Response or Morphologic Incomplete Response.
timeFrame: Complete Response or Morphologic Incomplete Response data not analyzed.
measure: Duration of Remission (DoR)
timeFrame: Duration of Remission (DoR) time frame not analyzed.
measure: Cytogenetic Complete Remission Rate (CRc)
timeFrame: Cytogenetic Complete Remission timeframe was not analyzed.
measure: Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)
timeFrame: Overall response rate time frame was not analyzed.
measure: Progression-Free Survival (PFS)
timeFrame: Progression-Free survival data and time frame was not analyzed.
measure: Event-Free Survival (EFS)
timeFrame: Event-Free survival time was not analyzed.
measure: Relapse-Free Survival (RFS)
timeFrame: Relapse-Free survival time frame was not analyzed.
measure: Percentage of Participants With 30-Day Treatment-Related Mortality
timeFrame: 30 days
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE)
timeFrame: From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018
measure: Number of Participants With a Second Primary Malignancy
timeFrame: From randomization of the last participant up to a minimum of 4 years following discontinuation
Other outcomes:
measure: Percentage of Participants Alive at One Year
timeFrame: Up to 12 months
Locations:
city: Tucson
country: United States
facility: (210) University of Arizona Cancer Center
state: Arizona
city: La Jolla
country: United States
facility: (180) University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: (240) Cedars-Sinai Medical Center
state: California
city: Orange
country: United States
facility: (215) Hematology Oncology Medical Group
state: California
city: Sacramento
country: United States
facility: (130) UC Davis Medical Center
state: California
city: San Luis Obispo
country: United States
facility: (200) Coastal Integrative Cancer Care
state: California
city: Stanford
country: United States
facility: (125) University of Stanford
state: California
city: Aurora
country: United States
facility: (115) University of Colorado Anschultz Cancer Center
state: Colorado
city: Miami Beach
country: United States
facility: (145) Mount Sinai Comprehensive Cancer Center
state: Florida
city: Chicago
country: United States
facility: (140) Rush University Medical Center
state: Illinois
city: Westwood
country: United States
facility: (185) The University of Kansas Cancer Center
state: Kansas
city: Louisville
country: United States
facility: (175) University Lousiville
state: Kentucky
city: New Orleans
country: United States
facility: (195) Tulane University Hospital Tulane Cancer Center
state: Louisiana
city: Minneapolis
country: United States
facility: (235) University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: (100) Washington University School of Medicine
state: Missouri
city: Billings
country: United States
facility: (150) Billings Clinic
state: Montana
city: New York
country: United States
facility: (165) Mount Sinai Medical Center New York
state: New York
city: Pittsburgh
country: United States
facility: (160) The Western Pennsylvania Hospital- Cancer Institute
state: Pennsylvania
city: Greenville
country: United States
facility: (205) Greenville Hospital System
state: South Carolina
city: Sioux Falls
country: United States
facility: (120) Avera Cancer Institute
state: South Dakota
city: Nashville
country: United States
facility: (230) Tennessee Oncology, PLLC
state: Tennessee
city: Dallas
country: United States
facility: (105) University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
state: Texas
city: San Antonio
country: United States
facility: (155) Cancer Care Centers of South Texas
state: Texas
city: Madison
country: United States
facility: (135) University of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: (402) Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: (405) University of Alberta Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: (401) Cancer Care Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: (403) Queen Elizabeth II Health Sciences Centre - VG Site
state: Nova Scotia
city: Ottawa
country: Canada
facility: (404) The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: (400) Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Celgene
name: Robert Gale, MD
role: STUDY_DIRECTOR
References:
citation: 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.