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A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy

This study has been terminated.
(Insufficient Enrollment)
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00362466
First received: August 9, 2006
Last updated: November 18, 2009
Last verified: November 2009
  Purpose

The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.


Condition Intervention Phase
Leukemia
Drug: Dasatinib
Drug: Imatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Complete Cytogenetic Response (CCyR) Rate at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Molecular Response (MMR) Rates [ Time Frame: Month 3, Month 6, Month 12, Month 24 and Month 36 ] [ Designated as safety issue: No ]
  • CCyR Rates [ Time Frame: Month 3, Month 12, Month 24 and Month 36 ] [ Designated as safety issue: No ]
  • Estimate Time to MMR and CCyR [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: at 36 months ] [ Designated as safety issue: No ]
  • Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs [ Time Frame: From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible. ] [ Designated as safety issue: Yes ]
  • Duration of CCyR and MMR [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Best MMR Rates [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: April 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
50-180 mg once daily (QD)
Drug: Dasatinib
Tablets, Oral, Once daily, 5-7 years
Other Name: Sprycel®
Active Comparator: B
200-800 mg QD
Drug: Imatinib
Tablets, Oral, Once daily, 5-7 years

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg
  • Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis
  • Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
  • Adequate hepatic and renal function

Exclusion Criteria:

  • Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant
  • Previous diagnosis of accelerated/blast crisis CML
  • Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases
  • Previous documentation of T315I mutation
  • Uncontrolled or significant cardiovascular disease
  • Serious uncontrolled medical disorder/active infection
  • History of significant bleeding disorder unrelated to CML
  • Intolerance to imatinib ≥400 mg
  • Concurrent malignancies other than CML
  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: NCT00362466

  Show 45 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00362466     History of Changes
Other Study ID Numbers: CA180-044
Study First Received: August 9, 2006
Results First Received: July 24, 2009
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Leukemia (chronic myeloid leukemia - chronic phase)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Dasatinib
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014