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Report for Clinical Trial NCT00362466

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib

The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.

NCT00362466 Leukemia
MeSH: Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO: Chronic myelogenous leukemia Leukemia Myeloid leukemia

2 Interventions

Name: Dasatinib

Description: Tablets, Oral, Once daily, 5-7 years

Type: Drug

A

Name: Imatinib

Description: Tablets, Oral, Once daily, 5-7 years

Type: Drug

B


Primary Outcomes

Measure: Complete Cytogenetic Response (CCyR) Rate at Month 6

Time: Month 6

Secondary Outcomes

Measure: Major Molecular Response (MMR) Rates

Time: Month 3, Month 6, Month 12, Month 24 and Month 36

Measure: CCyR Rates

Time: Month 3, Month 12, Month 24 and Month 36

Measure: Estimate Time to MMR and CCyR

Time: throughout the study

Measure: Progression Free Survival (PFS)

Time: at 36 months

Measure: Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs

Time: From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.

Measure: Duration of CCyR and MMR

Time: Throughout the study

Measure: Best MMR Rates

Time: throughout study

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T315I

Inclusion Criteria: - Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg - Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis - Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 - Adequate hepatic and renal function Exclusion Criteria: - Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant - Previous diagnosis of accelerated/blast crisis CML - Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases - Previous documentation of T315I mutation - Uncontrolled or significant cardiovascular disease - Serious uncontrolled medical disorder/active infection - History of significant bleeding disorder unrelated to CML - Intolerance to imatinib ≥400 mg - Concurrent malignancies other than CML Inclusion Criteria: - Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg - Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis - Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 - Adequate hepatic and renal function Exclusion Criteria: - Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant - Previous diagnosis of accelerated/blast crisis CML - Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases - Previous documentation of T315I mutation - Uncontrolled or significant cardiovascular disease - Serious uncontrolled medical disorder/active infection - History of significant bleeding disorder unrelated to CML - Intolerance to imatinib ≥400 mg - Concurrent malignancies other than CML Leukemia Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive null --- T315I ---

Inclusion Criteria: - Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg - Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis - Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 - Adequate hepatic and renal function Exclusion Criteria: - Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant - Previous diagnosis of accelerated/blast crisis CML - Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases - Previous documentation of T315I mutation - Uncontrolled or significant cardiovascular disease - Serious uncontrolled medical disorder/active infection - History of significant bleeding disorder unrelated to CML - Intolerance to imatinib ≥400 mg - Concurrent malignancies other than CML Inclusion Criteria: - Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg - Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis - Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 - Adequate hepatic and renal function Exclusion Criteria: - Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant - Previous diagnosis of accelerated/blast crisis CML - Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases - Previous documentation of T315I mutation - Uncontrolled or significant cardiovascular disease - Serious uncontrolled medical disorder/active infection - History of significant bleeding disorder unrelated to CML - Intolerance to imatinib ≥400 mg - Concurrent malignancies other than CML Leukemia Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive null --- T315I --- --- T315I ---



HPO Nodes


HPO:
Chronic myelogenous leukemia
Genes 9
KIT MPL ASXL1 TET2 ABL1 JAK2 THPO BCR SRSF2
Leukemia
Genes 190
ATM KRAS KIT RPS15A NF1 MPL RPL35A RPL11 RPL18 DDX41 SBDS LPP ETV6 BUB1B F13A1 DNMT3A JAK2 NUP214 FANCD2 MSH6 FANCA PIGL NRAS TCIRG1 BUB1 TET2 FLT3 TAL1 ATRX TREX1 PDGFRA SRP54 RPS29 PTPN11 CALR FANCE WIPF1 SF3B1 GATA2 GLI1 STS SH3GL1 XRCC4 MPL SH2B3 EFL1 PIGA TREM2 CBL MPL RUNX1 MPL PIGL THPO FANCG NSD1 BRD4 NSUN2 SH2B3 RARA GATA2 NPM1 CBL CHIC2 ERBB3 GFI1 TERT KIT BCR ARHGAP26 DYNC2LI1 EVC SCN10A GATA1 ELANE RNASEH2B RPS14 SH2B3 JAK2 RPL15 SBDS NRAS RPL26 RPL27 ADA2 RPS7 TYROBP F13B MSH2 BCR WAS TERC TP53 TRIP13 MYD88 NUTM1 RPS24 GNB1 TP53 DNMT3A TERT NUMA1 NUP214 RPL5 SAMD9L TET2 CFTR POT1 FANCC RPS10 EP300 EVC2 BUB1B CEBPA BRCA2 DNAJC21 CALR SCN9A LIG4 ADAR BLM TET2 JAK2 SMPD1 RNASEH2C SCN11A GATA2 BUB3 PRSS1 KIF11 BCR RPL35 TAL2 SRP54 IFIH1 ABL1 PDGFRB KRAS RNASEH2A TET2 MLLT10 SRP54 DNAJC21 DKC1 RUNX1 APC LIG4 CBFB BLM THPO CALR NBN JAK2 MLH1 RPS19 ELANE SAMD9L RPL31 PMS2 ASXL1 TSR2 MLF1 PIK3CA DNAJC21 RUNX1 GFI1 SRSF2 SETBP1 HAX1 RPS26 RPS17 FLT3 RPS27 PIK3R1 KRAS CEP57 PICALM CREBBP GATA2 CTRC MYD88 TET2 RPS28 ABL1 RB1 SPINK1 GATA1 NBN JAK2 SAMHD1
Myeloid leukemia
Genes 20
KIT SETBP1 NF1 ARHGAP26 CBL TET2 KRAS PTPN11 F13A1 SAMD9L SAMD9L GATA2 CBL ASXL1 DNMT3A F13B NRAS SRSF2 TERC TERT