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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
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: