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Report for Clinical Trial NCT00802841

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Phase Lll Study of Imatinib Dose Optimization Compared With Nilotinib in Patients With Chronic Myelogenous Leukemia and Suboptimal Response to Standard-dose Imatinib

There is no available data on the clinical benefit of dose escalation for patients with suboptimal response to imatinib, and patients may still improve their response with continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of follow-up. However, there is no data yet regarding the potential benefit of using nilotinib in the group of patients with suboptimal response. In this study, the efficacy of nilotinib 400mg BID will be compared to imatinib 600mg QD.

NCT00802841 Chronic Myelogenous Leukemia
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

2 Interventions

Name: nilotinib

Description: Supplied as 200 mg tablets
Type: Drug
Group Labels: 1

Nilotinib

Name: imatinib

Description: Supplied as 100 mg and 400 mg tablets
Type: Drug
Group Labels: 1

Imatinib


Primary Outcomes

Description: CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.

Measure: Percentage of Participants With Complete Cytogenetic Response (CCyR)

Time: 6 months

Secondary Outcomes

Description: MMR was defined as having a fusion gene of the Bcr and Abl genes of (BCR-ACL) less than or equal to 0.1% on the International Scale (IS).

Measure: Percentage of Participants With Major Molecular Response (MMR)

Time: 12 and 24 months

Description: CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.

Measure: Percentage of Participants With CCyr

Time: 12 and 24 months

Description: Time to CCyR was defined as time from date of randomization to date of first documented CCyR.

Measure: Time to CCyR

Time: 24 months

Description: Duration of CCyR was defined as time from the date of ransomization to the date of first loss of CCyR or death, whichever came first.

Measure: Duration of CCyR

Time: 24 months

Description: PFS was defined as the time from the date of randomization to the date of documented disease progression to accelerated phase or blast crisis (AP/BC), or death due to any cause.

Measure: Progression-Free Survival (PFS)

Time: 24 months

Description: EFS was defined as the time from the date of randomization to the date of the first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of Partial Cytogenetic Response (PCyR), loss of CCyR, death on treatment or progression to AP/BC.

Measure: Event-Free Survival (EFS)

Time: 24 months

Description: OS was defined as time from date of randomization to the date of the death.

Measure: Overall Survival (OS)

Time: 24 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T315I

Exclusion criteria: 1. Prior accelerated phase including clonal evolution or blast crisis CML; 2. Prior therapy with imatinib in combination with any other CML drug other than Hydroxyurea and/or Anagrelide; 4.Imatinib therapy started more than 12 months after the date of the original diagnosis; 5.Unable to tolerate imatinib at 400mg; 6.Previous treatment with any other tyrosine kinase inhibitor except Glivec and/or CML therapy other than IFN, hydroxyurea, and /or anagrelide; 7.Myelotoxicity ≥ Grade 2 present at the time of randomization, 8.Previously documented T315I mutations; 9.Impaired cardiac function including one of these: - Long QT syndrome or family history of long QT syndrome - Clinically significant resting brachycardia (<50 bpm) - QTcF >450 msec on screening ECG (using the QTcF formula). --- T315I ---



HPO Nodes


HPO: