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Report for Clinical Trial NCT00980018

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Exploratory Trial to Assess the Improvement of Chronic Low-grade Non-hematologic Adverse Events Experienced by Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Treated With Imatinib When Switched to Nilotinib Treatment

The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.

NCT00980018 Chronic Myelogenous Leukemia
MeSH: Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO: Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Nilotinib

Description: participants will take nilotinib 400mg twice daily by mouth every morning and every evening approximately 12 hours apart. Participants will take two 200mg capsules at each dosing. Nilotinib is taken on an empty stomach with 8 ounces of water. No food is to be eaten for 2 hours prior to the nilotinib dose or for one hour following the dose.

Type: Drug

nilotinib


Primary Outcomes

Measure: Improvement of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with nilotinib at End of Cycle 3

Time: 3 months

Secondary Outcomes

Description: Assess CCyR by bone marrow cytogenics

Measure: Rate of Complete Cytogenetic Response (CCyR) present at baseline

Time: 6, 12, and 18 months after starting imatinib. FISH wil be conducted at the end of cycles 1,2,3,6,9,12 after the switch to nilotinib

Description: Measure MMR at the end of Cycles

Measure: Rate of a Major Molecular Response (MMR) after the switch in the therapy

Time: 1,2,3,6,9,12 after the switch to nilotinib

Measure: Magnitude of Bcr-Abl change after the switch in therapy

Time: At the end of cycles 1,2,3,6,9, and 12 after the switch to nilotinib.

Measure: Durability of cytogenetic and molecular response

Time: after the switch to nilotinib until the end of the study

Measure: Time to optimal imatinib-related adverse event improvement

Time: time to first documented and optimal improvement of adverse events associated with imatinib and to the end of the study

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 T315I

Inclusion Criteria: 1. Male or female patients ≥ 18 years of age 2. ECOG 0, 1, or 2 3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS) 4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol 5. CML-CP patients initiated on any dose of imatinib 6. Ability to provide written informed consent prior to any study related screening procedures being done Exclusion Criteria: 1. Loss of CHR or cytogenetic response 2. Prior accelerated phase or blast phase CML 3. Previously documented T315I mutation 4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+. 5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib. --- T315I ---

Other protocol-defined inclusion/exclusion criteria may apply Inclusion Criteria: 1. Male or female patients ≥ 18 years of age 2. ECOG 0, 1, or 2 3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS) 4. Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol 5. CML-CP patients initiated on any dose of imatinib 6. Ability to provide written informed consent prior to any study related screening procedures being done Exclusion Criteria: 1. Loss of CHR or cytogenetic response 2. Prior accelerated phase or blast phase CML 3. Previously documented T315I mutation 4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+. 5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib. --- 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