SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02115386

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Open-label Multicenter Trial to Evaluate the Improvement of Chronic Low-grade Adverse Events Experienced by Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) With Optimal Response to Imatinib When Switched From Imatinib to Nilotinib Treatment

Primary Objective for this study is to evaluate changes in chronic low grade non-hematological adverse events experienced by patients who have been treated with at least 6 months of imatinib and who have not responded to supportive measures, when they are switched to nilotinib (CTCAE grading system).

NCT02115386 Philadelphia Positive (Ph+) Chronic Myeloid Leukemia
MeSH: Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO: Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Nilotinib

Description: 300 mg

Type: Drug

Nilotinib


Primary Outcomes

Description: To evaluate improvement in chronic low grade non-hematological adverse events, experienced by patients treated with imatinib and persistent despite best supportive measures, when patients are switched from imatinib to nilotinib at 6 months after switch

Measure: improvement of grades of persistent non-hematological AE grade

Time: at 6 month after switching from imatinib to nilotinib

Secondary Outcomes

Description: to evaluate improvement of low-grade non-hematologic adverse events, experiences by patients treated with imatinib and persistent despite of best supportive measures after switching to nilotinib therapy

Measure: improvement of chronic low-grade non-hematologic AEs

Time: at 3 month after switching from imatinib to nilotinib

Description: to evaluate CCyR after switching (both newly achieved or maintained)

Measure: rate of CCyR

Time: at months 6,12 and 24 after switching from imatinib to nilotinib

Description: to evaluate MMR after switching

Measure: rate of MMR

Time: at months 1,3, 6, 9, 12, 18 and 24 after switching from imatinib to nilotinib

Description: to evaluate time to achievement and duration of CCyR and MMR after switching

Measure: time to and duration of CCyR and MMR

Time: 24 Months

Description: to evaluate time to first improvement of low-grade non-hematologic adverse events, experiences by patients treated with imatinib and persistent despite of best supportive measures after switching to nilotinib therapy. Optimal improvement is defined as AE grade decreasing to 0.

Measure: time to first improvement of chronic low-grade non-hematologic AEs

Time: 24 Months

Description: to evaluate overall nilotinib safety profile in study

Measure: summary of biochemistry and hematology AE/SAEs reported

Time: 24 Months

Description: to evaluate quality of life changes after switching to nilotinib

Measure: QOL changes

Time: at months 1,3,6,12 and 24 after switch to nilotinib

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 T315I

- Ability to provide written informed consent prior to any study related screening procedures being done - minimal duration of imatinib therapy 6 months Exclusion Criteria: - Loss of response (hematologic, cytogenetic, molecular) any time prior to inclusion - Prior accelerated phase or blast phase CML - Previously documented T315I mutation - Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+. - Any grade >2 non-hematological AEs at inclusion and within 30 days prior to inclusion. --- T315I ---



HPO Nodes


HPO:
Chronic myelogenous leukemia
Genes 5
MPL BCR JAK2 KIT THPO
Leukemia
Genes 125
MPL RNASEH2B KRAS NPM1 TET2 MYD88 TSR2 RPL26 RPL27 TREX1 EFL1 PIGL SCN11A FLT3 PMS2 RPL35A EVC2 ABL1 CEBPA RARA NRAS WAS WIPF1 ATRX SH2B3 PDGFRA RB1 RNASEH2A PDGFRB CALR ARHGAP26 SH3GL1 RPS7 RPS10 NUMA1 GATA1 GATA2 RPS15A APC NSD1 ETV6 TCIRG1 DNAJC21 EVC SRP54 RPS17 NBN RPS19 SAMHD1 MSH2 RPS24 NUP214 RPS26 RPS27 RPS28 RPS29 MLLT10 RUNX1 XRCC4 CBFB CBL BCR ADAR TRIP13 ADA2 NSUN2 CREBBP PICALM GFI1 F13A1 F13B FANCA FANCC BLM FANCD2 FANCE NUTM1 JAK2 IFIH1 TYROBP MSH6 FANCG LIG4 PTPN11 SAMD9L THPO NF1 STS PIGA BRCA2 DYNC2LI1 PIK3CA SBDS GLI1 PIK3R1 BRD4 SETBP1 RNASEH2C LPP BUB1 BUB1B SCN9A SCN10A TREM2 MLF1 MLH1 ELANE DKC1 ATM HAX1 RPL35 GNB1 BUB3 CEP57 TAL1 KIT TAL2 RPL5 EP300 TP53 RPL11 KIF11 RPL15 DNMT3A RPL18
Myeloid leukemia
Genes 12
GATA2 F13A1 CBL ARHGAP26 F13B KRAS PTPN11 SAMD9L KIT SETBP1 NF1 NRAS