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Report for Clinical Trial NCT01004497

Developed by Shray Alag, 2020.
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 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
Lymphoid leukemia