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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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358734
First Posted: May 24, 2011
Last Update Posted: March 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
May 19, 2011
May 24, 2011
April 4, 2016
July 4, 2016
March 14, 2017
April 2012
April 2015   (Final data collection date for primary outcome measure)
Kaplan Meier Estimates for One Year Survival [ Time Frame: Up to 24 months ]
Overall Survival (OS) was defined as the time from randomization to death from any cause. OS was calculated using the date of randomization and date of death, or date of last follow-up for censored participants.
Number of participants alive [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01358734 on ClinicalTrials.gov Archive Site
  • Remission Rate (CR + CRi) [ Time Frame: Up to 74 months ]
    Remission Rate was defined as CR + CRi). Morphologic complete remission (CR) was defined as a leukemia-free state defined as less than 5% blasts in a bone marrow aspirate with bone marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods or persistence of extra-medullary disease) AND an absolute neutrophil count (ANC) of > 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, and Red Blood Cell transfusion (RBC) independence (no RBC transfusions for 1 week before each assessment). Morphologic complete remission with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC (Absolute Neutrophil Count) may be < 1 x 10^9/L or plateletsmay be < 100 x 10^9/L.
  • Duration of Remission (DoR) [ Time Frame: Up to 74 months ]
    Duration of remission defined as the time from the date a response of CR or CRi is first documented until the date the participant has documented relapse after CR or CRi or dies from any cause, whichever occurs first.
  • Cytogenetic Complete Remission Rate (CRc) [ Time Frame: Up to 74 months ]
    The CRc response category is comprised of the subset of participants who had abnormal ctyogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment
  • Percentage of Participants With an Overall Response Rate (CR +CRi+ PR) [ Time Frame: Up to 74 months ]
    Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods) AND an absolute neutrophil count (ANC) of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery (CRi) is defined as a morphologic complete remission but the ANC may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Partial remission (PR) is defined as an ANC > 1 x 10^9/L and platelet count ≥ 100 x 10^9/L with a > 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if Auer rods are present).
  • Progression-Free Survival (PFS) [ Time Frame: Up to 74 months ]
    PFS is defined as the time from randomization to the first observation of documented disease progression or death due to any cause whichever occurs first.
  • Event-Free Survival (EFS) [ Time Frame: Up to 74 months ]
    EFS is defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurs first
  • Relapse-Free Survival (RFS) [ Time Frame: Up to 74 months ]
    Relapse-free survival is defined only for participants who achieve a CR or CRi and is measured as the interval from the date of first documented leukemia-free state (defined as less than 5% blasts in an aspirate sample) to the date of leukemia relapse, death from any cause, whichever occurs first, censoring at the last visit date for participants alive in continuous CR or CRi.
  • Percentage of Participants With 30-day Treatment-related Mortality [ Time Frame: 30 days ]
    30-day mortality rate is defined as death from any cause within 30 days after first dose.
  • Number of Participants With Treatment Emergent Adverse Events (TEAE) [ Time Frame: Up to data cut-off of 01 May 2015; 36 months and 4 days ]
    TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death
  • Number of participants in remission [ Time Frame: Approximately 12 months ]
  • Duration of remission [ Time Frame: Approximately 12 months ]
  • Number of participants with a cytogenetic complete remission rate [ Time Frame: Approximately 12 months ]
  • Number of participants who have a response (Complete Remissions plus Morphologic Complete Remissions with incomplete blood count recovery plus Partial Remissions) [ Time Frame: Approximately 12 months ]
  • Number of participants who survive without worsening of disease [ Time Frame: Approximately 12 months ]
  • Number of participants who survive without an event [ Time Frame: Approximately 12 months ]
  • Number of participants who survive without relapsing [ Time Frame: Approximately 12 months ]
  • Number of participants who died [ Time Frame: 30 days ]
  • Number of participants with adverse events [ Time Frame: Approximately 12 months ]
Percentage of Participants Alive at One Year [ Time Frame: Up to 12 months ]
Percentage of participants who survived at one year
Not Provided
 
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
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
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).
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Acute Myelogenous Leukemia
  • Drug: Azacitidine
    Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7
    Other Name: Vidaza
  • Drug: 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
    Other Names:
    • Revlimid®
    • CC-5013
  • Other: 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

  • Experimental: 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
    Interventions:
    • Drug: Azacitidine
    • Drug: Lenalidomide
    • Other: Best Supportive Care (BSC)
  • Experimental: 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
    Interventions:
    • Drug: Lenalidomide
    • Other: Best Supportive Care (BSC)
  • Experimental: 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
    Interventions:
    • Drug: Azacitidine
    • Other: Best Supportive Care (BSC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
88
May 2018
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01358734
CC-5013-AML-001
Yes
Not Provided
Not Provided
Celgene
Celgene
Not Provided
Study Director: Robert Gale, MD Celgene
Celgene
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP