A Study Being Conducted at Multiple Locations to Compare the Safety and Effectiveness of Three Different Treatment Regimens; 1) Lenalidomide, 2) Lenalidomide + Azacitidine, or 3) Azacitidine Alone in Newly Diagnosed Acute Myeloid Leukemia in Elderly Subjects ≥ 65 Years of Age

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01358734
First received: May 19, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

The aim of the study is to investigate the effect of a lenalidomide regimen, a sequential azacitidine plus lenalidomide regimen or an azacitidine regimen in elderly subjects 65 years or older with newly diagnosed AML.


Condition Intervention Phase
Acute Myeloid Leukemia
Acute Myelogenous Leukemia
Drug: Azacitidine-single agent
Drug: Lenalidomide - single agent
Drug: Lenalidomide in combination with azacitidine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Survival [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
    Proportion of surviving subjects


Secondary Outcome Measures:
  • Remission Rate [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Number of subjects achieving remission

  • Remission Duration [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Length of time subject remains in remission

  • Cytogenetic Complete Remission Rate [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Number of subjects achieving cytogenetic complete remission

  • Overall Response Rate [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Number of subjects who respond

  • Progression-free survival [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Number of subjects who survive without progression

  • Event-free survival [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Number of subjects who survival without an event

  • Relapse-free survival [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Number of subjects surviving without relapse

  • 30-day treatment-related mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Number of subjects who die with 30 days from treatment

  • Safety and Tolerability [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    Number of subjects with adverse events


Enrollment: 88
Study Start Date: August 2011
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide in combination with azacitidine
Repeated cycles of azacitidine 75 mg/m2/day subcutaneous on Days 1-7 and lenalidomide 50 mg/day by mouth on Days 8-28 followed by a 14-day break plus best supportive care
Drug: Azacitidine-single agent
Azacitidine at 75 mg/m2/day subcutaneous on Days 1-7
Other Name: Azacitidine
Drug: Lenalidomide in combination with azacitidine
Repeated cycles of azacitidine 75 mg/m2/day subcutaneous on Days 1-7 and lenalidomide 50 mg/day by mouth on Days 8-28 followed by a 14-day break plus best supportive care
Other Names:
  • Azacitidine
  • Lenalidomide
Experimental: Lenalidomide - single agent
Lenalidomide 50 mg/day by mouth for 28 days for the first 2 cycles and lenalidomide 25 mg/day by mouth for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg/day by mouth plus best supportive care
Drug: Lenalidomide - single agent
Lenalidomide 50 mg/day by mouth x 28 days for the first 2 cycles and lenalidomide 25 mg/day by mouth x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg/day by mouth
Other Name: Revlimid
Experimental: Azacitidine-single agent
Repeated cycles of azacitidine 75mg/m2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care
Drug: Azacitidine-single agent
Azacitidine at 75 mg/m2/day subcutaneous on Days 1-7
Other Name: Azacitidine

Detailed Description:

Randomization into the lenalidomide alone arm has been temporarily suspended pending review and modification of the dosing schedule. The study continues with recruitment in the other two arms.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358734

  Show 30 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Robert Gale, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01358734     History of Changes
Other Study ID Numbers: CC-5013-AML-001
Study First Received: May 19, 2011
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
AML
elderly
acute myelogenous leukemia
vidaza
azacitidine
elderly AML
revlimid
lenalidomide

Additional relevant MeSH terms:
Lenalidomide
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Thalidomide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014