Dasatinib Combined With Chemotherapy in Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
NCT02523976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-02-11
Summary
In this single-center, open-label, no control,prospective clinical trial, a total of 30 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) patients will be enrolled. Dasatinib 100 mg per day will be given orally along with combination chemotherapy starting day 8 of induction chemotherapy. Dasatinib will be given continuously (if it's tolerable) for 2 years since achievement of complete remission (CR) as part of consolidation chemotherapy and maintenance therapy.Patients can receive allogeneic hematopoietic stem cell transplantation (HSCT) or autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation chemotherapy. The purpose of current study is to determine the clinical efficacy and tolerability of combination therapy of Dasatinib with multi-agent chemotherapy in newly-diagnosed Ph+ ALL.
Conditions
- Acute,Leukemia, Lymphoid
Interventions
- DRUG
-
vincristine
- DRUG
- DRUG
-
mercaptopurine
- DRUG
-
methotrexate
- DRUG
- DRUG
-
mitoxantrone
- DRUG
-
etoposide
- PROCEDURE
-
allogeneic hematopoietic stem cell transplantation
- PROCEDURE
-
autologous hematopoietic stem cell transplantation
- DRUG
-
Second-generation tyrosine kinase inhibitor
- DRUG
- DRUG
- DRUG
-
daunorubicin
Sponsors & Collaborators
-
Institute of Hematology & Blood Diseases Hospital, China
lead OTHER
Principal Investigators
-
Jianxiang Wang, Dr. · Institute of Hematology & Blood Diseases Hospital, China
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-08-01
- Primary Completion
- 2021-12-31
- Completion
- 2021-12-31
Countries
- China
Study Locations
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