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Report for Clinical Trial NCT00866736

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia

The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.

NCT00866736 Chronic Myeloid Leukemia
MeSH: Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO: Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: dasatinib

Description: 100mg QD

Type: Drug

dasatinib


Primary Outcomes

Measure: rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects

Time: at 12 months

Secondary Outcomes

Measure: safety after treatment with dasatinib

Time: 2 year

Measure: rate of Complete Cytogenetic Response(CCyR)

Time: 2 year

Measure: rate of Complete Hematologic Response (CHR)

Time: 2 year

Measure: efficacy on patients with BCR-ABL point mutations

Time: 2 year

Measure: progression free survival

Time: 2 year

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 2 SNPs

SNPs


1 F317L

- Prior therapy with dasatinib - Subjects with T315I and/or F317L BCR-ABL point mutations Inclusion Criteria: - Signed Written Informed Consent - Subjects with chronic phase chronic myeloid leukemia (CML) - Subjects resistant/intolerant to imatinib - Subjects presenting: 1. ECOG performance status (PS) score 0-2 2. Adequate hepatic function 3. Adequate renal function 4. Adequate lung function Exclusion Criteria: - Concurrent malignancy other than CML - Women who are pregnant or breastfeeding - Concurrent pleural effusion - Uncontrolled or significant cardiovascular disease - A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy. --- T315I --- --- F317L ---

- Prior therapy with dasatinib - Subjects with T315I and/or F317L BCR-ABL point mutations Chronic Myeloid Leukemia Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive null --- T315I --- --- F317L ---


2 T315I

- Prior therapy with dasatinib - Subjects with T315I and/or F317L BCR-ABL point mutations Inclusion Criteria: - Signed Written Informed Consent - Subjects with chronic phase chronic myeloid leukemia (CML) - Subjects resistant/intolerant to imatinib - Subjects presenting: 1. ECOG performance status (PS) score 0-2 2. Adequate hepatic function 3. Adequate renal function 4. Adequate lung function Exclusion Criteria: - Concurrent malignancy other than CML - Women who are pregnant or breastfeeding - Concurrent pleural effusion - Uncontrolled or significant cardiovascular disease - A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy. --- T315I ---

- Prior therapy with dasatinib - Subjects with T315I and/or F317L BCR-ABL point mutations Chronic Myeloid Leukemia Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive null --- 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