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Report for Clinical Trial NCT00471497

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol is included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive nilotinib therapy at a dose of 400 mg BID, using an abbreviated safety and efficacy assessment schedule. The extension protocol CAMN107A2303E1 (NCT00718263) was registered incorrectly as a separate study. But this study has now been suppressed.

NCT00471497 Myelogenous Leukemia, Chronic
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

2 Interventions

Name: nilotinib

Description: Nilotinib was supplied as 50 mg, 150 mg and 200 mg hard gelatin capsules and administered orally at 300 mg BID (twice a day) or 400 mg BID (twice a day)depending on the randomized dose.
Type: Drug
Group Labels: 2

Nilotinb 400 mg bid (investigating arm) nilotinib 300mg bid (investigating arm)

Name: imatinib

Description: Imatinib was supplied as 100 mg and 400 mg tablets and administered orally at 400 mg QD (once a day).
Type: Drug
Group Labels: 1

imatinib 400mg QD (control arm)

Primary Outcomes

Description: Rate of MMR is defined as <= 0.1% BCR-ABL/ABL ratio by international scale (IS), measured by real-time quantitative polymerase chain reaction (RQ-PCR) which corresponds to a ≥ 3 log reduction of BCR-ABL transcript from standardized baseline. BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson protooncogene)

Measure: Molecular Response Rate (MMR) at 12 Months

Time: Baseline, 12 months

Secondary Outcomes

Measure: Rate of Durable MMR at 24 Months.

Time: Baseline, 24 months

Measure: Rate Reduction in BCR-ABL Transcript Levels in Nilotinib Treatment Arms With Imatinib at 12 Months

Time: Baseline, 12 months

Measure: Rate of Complete Cytogenetic Response (CCyR) in Nilotinib Treatment Arms With Imatinib at 12 Months

Time: Baseline, 12 months

Purpose: Treatment

Allocation: Randomized

Single Group Assignment

There is one SNP


1 T315I

- Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome of (9:22) translocations Exclusion criteria: - Previously documented T315I mutation - Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except for no more than 2 weeks in duration of imatinib - Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide - Impaired cardiac function. --- T315I ---

HPO Nodes