Dasatinib Combined With Chemotherapy in Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Condition: Acute,Leukemia, Lymphoid
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Philadelphia Chromosome
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      In this single-center, open-label, Phase II study, nonrandomized,no control,prospective
      clinical trial,a total of 30 Philadelphia chromosome-positive acute lymphoblastic leukemia
      (Ph+ALL) patients will be enrolled.Patients will be diagnosed according to
      morphologic,immunologic, cytogenetic and molecular(MICM) criteria, including bone marrow
      morphology, immunophenotype, cytogenetic and molecular genetic (BCR/ABL gene, qualitative and
      quantitative analysis) examination.

      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 patients who keep BCR/ABL negative can receive autologous HSCT
      whenever possible during their first CR. Otherwise, they will finish the consolidation
      chemotherapy. Total duration of follow-up will be 2 year after last enrollment.

      Pre-treatment evaluation will include complete blood count (CBC) with reticulocyte count,
      chemistry, electrolytes, coagulation, hepatitis profile, chest X-ray.Evaluation during
      treatment will include: CBC every two days during myelosuppression, chemistry, electrolytes,
      coagulation before each cycles of chemotherapy. Quantitative PCR (RQ-PCR) for Bcr-Abl will be
      done from bone marrow mononuclear cells at diagnosis, at CR, and before each cycles of
      consolidation chemotherapy,then every 3 months during maintenance therapy. For patients who
      undergo allogeneic HSCT, quantitative PCR for Bcr-Abl will be done from bone marrow
      mononuclear cells at the initiation of conditioning, and then every 3 months. PCR will be
      done in IS standardized lab.

      Side effects of combination therapy will be monitored and described according to Common
      Toxicity Criteria, version 4.0 (National Cancer Institute, USA).

      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.
    

Intervention name(s): Dasatinib; prednisone; cyclophosphamide; daunorubicin; vincristine; cytarabine; mercaptopurine; methotrexate; dexamethasone; mitoxantrone; etoposide; allogeneic hematopoietic stem cell transplantation; autologous hematopoietic stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): Second-generation tyrosine kinase inhibitor
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisone; Cyclophosphamide; Methotrexate; Etoposide; Vincristine; Daunorubicin; Dasatinib; Mitoxantrone; Mercaptopurine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute; Leukemia; Lymphoid; Philadelphia chromosome; dasatinib