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Trial record 1 of 1 for:    NCT01358734
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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 currently recruiting participants.
Verified May 2013 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01358734
First received: May 19, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Number of Elderly Subjects Alive [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of elderly subjects in remission [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Duration of remission [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Number of elderly subjects with a cytogenetic complete remission rate [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Number of elderly subjects who have a response (Complete Remissions plus Morphologic Complete Remissions with incomplete blood count recovery plus Partial Remissions) [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Number of elderly subjects who survive without worsening of disease [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Number of elderly subjects who survive without an event [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Number of elderly subjects who survive without relapsing [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Number of elderly subjects who died [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of elderly subjects with adverse events [ Time Frame: Approximately 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2014 (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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Contacts
Contact: Associate Director, Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

  Show 30 Study Locations
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: CL Beach, PharmD 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: May 13, 2013
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:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Azacitidine
Lenalidomide
Thalidomide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
 Therapeutic Uses
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013