Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (ENEST)
This study has been terminated.
(This study was terminated due to limited enrollment.)
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00519090
First received: August 17, 2007
Last updated: November 4, 2011
Last verified: November 2011
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Purpose
In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
| Condition | Intervention | Phase |
|---|---|---|
|
Myelogenous Leukemia |
Drug: Imatinib Drug: Nilotinib (AMN107) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib [ Time Frame: 12 months ] [ Designated as safety issue: No ]Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Secondary Outcome Measures:
- Durable Complete Cytogenetic Response Rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
| Enrollment: | 6 |
| Study Start Date: | October 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Nilotinib (AMN107) |
Drug: Nilotinib (AMN107)
Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.
|
| Active Comparator: Imatinib |
Drug: Imatinib
Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days.
Other Names:
|
Detailed Description:
This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to < 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to < 18 months and having partial cytogenetic response (PCyR), but no CCyR.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.
Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:
- 6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or
- 12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH [fluorescence in situ hybridization] analysis was allowed).
Exclusion criteria:
- Patient who have received more than 18 months of imatinib therapy
- Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
- Prior treatment with greater than 400 mg/day imatinib.
- Uncontrolled or significant cardiovascular disease.
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
- Currently taking certain medications that could affect the rhythm of your heart.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519090
Show 80 Study Locations
Show 80 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00519090 History of Changes |
| Other Study ID Numbers: | CAMN107A2302 |
| Study First Received: | August 17, 2007 |
| Results First Received: | November 11, 2010 |
| Last Updated: | November 4, 2011 |
| Health Authority: | United States: Food and Drug Administration European Union: European Medicines Agency |
Keywords provided by Novartis:
|
leukemia bone marrow leukemia symptoms cml complete blood count lymphocyte blood cancer leukocytes chronic leukemia bone marrow biopsy leukemia research leukemia cells bone marrow disease |
chronic myeloid leukemia blood cancer symptoms white blood cell diseases chronic myelogenous leukemia leukemia treatment leukemia facts leucemia facts about leukemia myelogenous leukemia newly diagnosed CML suboptimal response Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013