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Report for Clinical Trial NCT01400074

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase III Multi-center, Open-label, Randomized Study of the Efficacy of Nilotinib Versus Imatinib in Adult Patients With Ph+ CML in Early CP Who Have a Suboptimal Molecular Response to Imatinib

In this study, the efficacy of nilotinib at 400 mg BID will be compared with imatinib at 400 mg BID in suboptimal molecular response patients. To determine study eligibility, suboptimal molecular response will be defined as patients who have achieved a complete cytogenetic response (CCyR) but have not achieved a MMR, after at least 18 months of treatment on first line imatinib therapy at a minimum dose of 400mg daily (Baccarani 2006).

NCT01400074 Chronic Myeloid Leukemia
MeSH:Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia

1 Interventions

Name: Nilotinib, Imatinib

Description: Nilotinib: 400 mg twice daily Imatinib: 400 mg twice daily
Type: Drug
Group Labels: 2

Imatinib Nilotinib


Primary Outcomes

Description: To evaluate the cumulative rate of MMR at 12 months of nilotinib compared to imatinib in adult patients with Ph+ CML in early CP who have suboptimal molecular response to imatinib

Measure: the cumulative rate of MMR

Time: 12 months

Purpose: Treatment

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 T315I

- Previously documented T315I mutations. --- T315I ---



HPO Nodes


HPO: