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Report for Clinical Trial NCT00644878

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multi-center, Open-label, Exploratory Study of Bcr-Abl Kinetics in Adult Patients on Nilotinib With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) and a Suboptimal Molecular Response to Imatinib

This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib

NCT00644878 Chronic Myelogenous Leukemia - Chronic Phase
MeSH: Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Philadelphia Chromosome
HPO: Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Nilotinib

Description: Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose.

Type: Drug

Nilotinib


Primary Outcomes

Measure: Bcr-Abl levels measured by polymerase chain reaction testing

Time: at 12 months

Secondary Outcomes

Measure: Rate of major molecular response, measured by PCR

Time: yearly

Measure: Rate of log reduction in Bcr-Abl transcripts, measured by PCR

Time: yearly

Measure: Time to and duration of the best molecular response, measured by PCR

Time: at end of study

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T315I

Select Inclusion Criteria: - Male or female patients - 18 years of age with a con-firmed diagnosis of Ph+ CML-CP and CCyR - Patients treated with an imatinib dose of 400 mg qd (at least 6 consecutive months for Group 1 patients) - A suboptimal molecular response to imatinib defined as: - Group 1: Treated with 1 year of imatinib, CCyR but no MMR (Bcr-Abl levels >0.1%IS); - Group 2: No specific duration of imatinib required, achieved CCyR but has >1 log increase in Bcr-Abl transcript levels - Adequate end organ function Select Exclusion Criteria: - Prior accelerated phase or blast crisis CML - Patients achieving prior CCyR on imatinib who lost cytogenetic response prior to entering study - Previously documented T315I mutations - Prior therapy with any other tyrosine kinase inhibitor except imatinib - Patients with contraindications to receiving nilotinib, including concomitant medications Select Inclusion Criteria: - Male or female patients - 18 years of age with a con-firmed diagnosis of Ph+ CML-CP and CCyR - Patients treated with an imatinib dose of 400 mg qd (at least 6 consecutive months for Group 1 patients) - A suboptimal molecular response to imatinib defined as: - Group 1: Treated with 1 year of imatinib, CCyR but no MMR (Bcr-Abl levels >0.1%IS); - Group 2: No specific duration of imatinib required, achieved CCyR but has >1 log increase in Bcr-Abl transcript levels - Adequate end organ function Select Exclusion Criteria: - Prior accelerated phase or blast crisis CML - Patients achieving prior CCyR on imatinib who lost cytogenetic response prior to entering study - Previously documented T315I mutations - Prior therapy with any other tyrosine kinase inhibitor except imatinib - Patients with contraindications to receiving nilotinib, including concomitant medications Chronic Myelogenous Leukemia - Chronic Phase Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Philadelphia Chromosome null --- T315I ---

Select Inclusion Criteria: - Male or female patients - 18 years of age with a con-firmed diagnosis of Ph+ CML-CP and CCyR - Patients treated with an imatinib dose of 400 mg qd (at least 6 consecutive months for Group 1 patients) - A suboptimal molecular response to imatinib defined as: - Group 1: Treated with 1 year of imatinib, CCyR but no MMR (Bcr-Abl levels >0.1%IS); - Group 2: No specific duration of imatinib required, achieved CCyR but has >1 log increase in Bcr-Abl transcript levels - Adequate end organ function Select Exclusion Criteria: - Prior accelerated phase or blast crisis CML - Patients achieving prior CCyR on imatinib who lost cytogenetic response prior to entering study - Previously documented T315I mutations - Prior therapy with any other tyrosine kinase inhibitor except imatinib - Patients with contraindications to receiving nilotinib, including concomitant medications Select Inclusion Criteria: - Male or female patients - 18 years of age with a con-firmed diagnosis of Ph+ CML-CP and CCyR - Patients treated with an imatinib dose of 400 mg qd (at least 6 consecutive months for Group 1 patients) - A suboptimal molecular response to imatinib defined as: - Group 1: Treated with 1 year of imatinib, CCyR but no MMR (Bcr-Abl levels >0.1%IS); - Group 2: No specific duration of imatinib required, achieved CCyR but has >1 log increase in Bcr-Abl transcript levels - Adequate end organ function Select Exclusion Criteria: - Prior accelerated phase or blast crisis CML - Patients achieving prior CCyR on imatinib who lost cytogenetic response prior to entering study - Previously documented T315I mutations - Prior therapy with any other tyrosine kinase inhibitor except imatinib - Patients with contraindications to receiving nilotinib, including concomitant medications Chronic Myelogenous Leukemia - Chronic Phase Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Philadelphia Chromosome 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