SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01004497

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 2 Multicenter Study of First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

The main aim of the present study is to evaluate the clinical efficacy of first-line dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive acute lymphoblastic leukemia. In this study, the investigators will analyze the clinical outcomes for entire patient population as well as those for transplants, respectively. In addition, the results of this study will be compared to those of the investigators current study (imatinib plus conventional chemotherapy). The safety of this treatment will also be studied.

NCT01004497 Acute Lymphoblastic Leukemia
MeSH: Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid
HPO: Leukemia Lymphoid leukemia

7 Interventions

Name: Dasatinib

Description: After the completion of each induction and consolidation chemotherapy with recovery of leukocyte and platelet counts, dasatinib will be given as an alternative manner: 100 mg by mouth once daily for 4 weeks

Type: Drug

Modified Hyper-CVAD + Dasatinib

Name: Cyclophosphamide

Description: 300 mg/m2, IV for 2 hours, every 12 hours x 6 doses, days 1-3

Type: Drug

Modified Hyper-CVAD + Dasatinib

Name: Vincristine

Description: 1.4 mg/m2/day (maximum 2 mg/day), IV for 30 minutes, days 4 & 11

Type: Drug

Modified Hyper-CVAD + Dasatinib

Name: Daunorubicin

Description: 45 mg/m2/day, IV for 1 hour, days 4 & 11

Type: Drug

Modified Hyper-CVAD + Dasatinib

Name: Dexamethasone

Description: 40 mg/day, IV push, days 1-4 & days 11-14

Type: Drug

Modified Hyper-CVAD + Dasatinib

Name: Cytarabine

Description: 2 g/m2, IV for 3 hours, every 12 hours x 10 doses, days 1-5

Type: Drug

Modified Hyper-CVAD + Dasatinib

Name: Mitoxantrone

Description: 12 mg/m2/day, IV for 30 minutes, days 1-2

Type: Drug

Modified Hyper-CVAD + Dasatinib


Primary Outcomes

Measure: To determine the clinical efficacy of dasatinib plus conventional chemotherapy for newly diagnosed Ph-positive ALL in terms of major molecular response rate

Time: by the second 4-week dasatinib therapy

Secondary Outcomes

Measure: To evaluate the long-term clinical outcomes (including transplant outcomes) in terms of treatment toxicity, relapse, disease-free survival, and overall survival

Time: at 2 years after transplantation (for all transplants); at 2 years after starting dasatinib maintenance (for all non-transplants)

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T315I

Dasatinib, a potent dual BCR-ABL/SRC family kinase inhibitor, demonstrated 325-fold greater activity against native BCR-ABL compared with imatinib and has shown efficacy against all imatinib-resistant BCR-ABL mutations with the exception of T315I. --- T315I ---



HPO Nodes


HPO:
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
Lymphoid leukemia