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Report for Clinical Trial NCT01004497
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
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
Group Labels: 1 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
Group Labels: 1 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
Group Labels: 1 Modified Hyper-CVAD + Dasatinib
Name: Daunorubicin
Description: 45 mg/m2/day, IV for 1 hour, days 4 & 11
Type: Drug
Group Labels: 1 Modified Hyper-CVAD + Dasatinib
Name: Dexamethasone
Description: 40 mg/day, IV push, days 1-4 & days 11-14
Type: Drug
Group Labels: 1 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
Group Labels: 1 Modified Hyper-CVAD + Dasatinib
Name: Mitoxantrone
Description: 12 mg/m2/day, IV for 30 minutes, days 1-2
Type: Drug
Group Labels: 1 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
Allocation: N/A
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: