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Report for Clinical Trial NCT01357655

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).

The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.

NCT01357655 Leukemia
MeSH:Leukemia
HPO:Leukemia

2 Interventions

Name: Dasatinib

Description: Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response
Type: Drug
Group Labels: 2

Arm 1: Dasatinib Arm2: Dasatinib + BMS-833923

Name: BMS-833923

Description: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response
Type: Drug
Group Labels: 1

Arm2: Dasatinib + BMS-833923


Primary Outcomes

Description: Major molecular response (MMR) was assessed using BCR-ABL transcript levels measured by real-time quantitative polymerase chain reaction (qPCR). MMR was defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). Number of participants with MMR by timepoint are cumulative.

Measure: Number of Participants With Major Molecular Response

Time: Baseline up to 12 months

Secondary Outcomes

Measure: Complete Molecular Response at Any Time

Time: Baseline to End of study (approximately 48 months)

Measure: Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death

Time: Baseline to End of study (approximately 48 months)

Measure: Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation

Time: Baseline to End of study (approximately 48 months)

Measure: Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death

Time: Baseline to End of study (approximately 48 months)

Description: AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug.

Measure: Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death

Time: From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 T315A

- Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2 Exclusion Criteria: - Known Abl-kinase T315I or T315A mutation - Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition - Prior chemotherapy. --- T315I --- --- T315A ---


2 T315I

- Eastern Co-Operative Group (ECOG) Performance Status (PS) Score 0 - 2 Exclusion Criteria: - Known Abl-kinase T315I or T315A mutation - Serious or uncontrolled medical disorder (including infection or cardiovascular disease) or dementia or other serious psychiatric condition - Prior chemotherapy. --- T315I ---



HPO Nodes


HPO: