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Report for Clinical Trial NCT01605981

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II, Non Randomized, Open Label, Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase.

This is an open label, non randomized, prospective, multicenter, phase II clinical trial evaluating nilotinib 400 mg BID for the treatment of newly diagnosed CML-AP patients. Patients enrolled into the study will receive 400mg of nilotinib, orally, twice daily (800mg/day)

NCT01605981 Chronic Myeloid Leukemia (CML)
MeSH: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO: Chronic myelogenous leukemia

1 Interventions

Name: AMN107

Type: Drug

Nilotinib oral


Primary Outcomes

Description: The toxicity criteria will be evaluated according to National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 3.0.

Measure: To evaluate the safety and tolerability profile of nilotinib in newly diagnosed CML-AP

Time: 12 month

Description: To test the efficacy of nilotinib 400 mg BID in inducing complete cytogenetic response (CCyR) at 12 months in newly diagnosed CML-AP patients

Measure: To test the efficacy of nilotinib 400 mg BID

Time: 12 months

Secondary Outcomes

Description: Evaluate the rate of complete hematologic response (CHR) with nilotinib 400 mg BID at 3 months.

Measure: Evaluate the rate of complete hematologic response (CHR)

Time: 3 months

Description: Evaluate the Quality of Life by FACT-Leu Version 4 questionnaire at 3, 6, 9, 12, 15, 18 and 24 months.

Measure: Evaluate the Quality of Life

Time: 3, 6, 9, 12, 15, 18 and 24 months

Description: Evaluate the median time to achieve molecular response and the cumulative probability of obtaining molecular response during the first 2 years of treatment. This will be undertaken through the analysis of the best molecular response at 3, 6, 12, 18 and 24 months. MMR will be preferred and it will be defined as a BCR-ABL/ABL ratio ≤ 0.1% IS using RQ-PCR, but any log reduction between 1 and 4,5 logs will be considered a molecular response.

Measure: Evaluate the median time to achieve molecular response

Time: uring the first 2 years of treatment

Description: Evaluate the proportion of patients achieving CCyR at 3, 6, 12, 18 and 24 months or undetectable BCR-ABL levels at 12, 18 and 24 months as well as the duration of sustained response.

Measure: Evaluate the proportion of patients achieving CCyR

Time: 3, 6, 12, 18 and 24 months or undetectable BCR-ABL levels at 12, 18 and 24 months

Description: To correlate the probability of reaching MMR, CMR and CCyR with the risk of progression to blastic phase, relapse and overall survival.

Measure: To correlate the probability of reaching MMR, CMR and CCyR

Time: 2 years

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 T315I

- Treatment with tyrosine kinase inhibitors or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with the exception of HU and/or anagrelide - Previously documented T315I mutations; - Uncontrolled congestive heart failure or hypertension; - Myocardial infarction or unstable angina pectoris within past 12 months; - Significant arrhythmias, including history or presence of clinically significant ventricular or atrial tachyarrhythmias, clinically significant bradycardias, long QT syndrome and/or QTc > 450 msec on screening ECG (using the QTcF formula). --- T315I ---



HPO Nodes


HPO:
Chronic myelogenous leukemia
Genes 9
KIT MPL ASXL1 TET2 ABL1 JAK2 THPO BCR SRSF2