Low-dose Chemotherapy Combine With Tyrosine Kinase Inhibitor to Treat ph+ Acute Lymphoblastic Leukemia Patients

Study Overview
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Brief Summary
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The aim of our study is to improve the major molecular remission(MMR) rate and reduce the cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens and the dosage of Tyrosine Kinase Inhibitor (TKI). lower the classification of chemotherapy drugs, lower the side effect brought by which this would be a grateful news for the patients once this regimens gain a successful result, which is also the final aim of our efforts.

Detailed Description
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The investigators new therapy regimens: The investigators use dexamethasone 10mg/d(d3-d7) as pre-processing therapy, dasatinib 100mg (d1-d84) plus prednisone 60mg/m2 (d1-24), reduce to d32, as inductive treatment after inductive treatment, if the patient get major molecular remission, patient will get to consolidation therapy, that is methotrexate (MTX) 3g/m2 d1, if not, this patient would be excluded from our trail. after consolidation therapy, if the patient have matched bone marrow donor, the investigators will suggest the patient receipting allogens-stem cell transplantation, otherwise, autogens stem cell transplantation can also be considered once the patient have no applicable bone marrow donor. on the other side, if the patient still not get MMR after this two cycle, maybe the patient can try Car-T, or other chemotherapy regimens.

Official Title
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The Combination of Lower Dosage of Chemotherapy With Tyrosine Kinase Inhibitor to Treat Newly Diagnosed ph+ Acute Lymphoblastic Leukemia Patients

Conditions
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ph+ Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: Dasatinib
* Drug: prednisone
* Drug: dexamethasone
* Drug: methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Get signed the informed consent of patients and family members Age ≥ 18 one full year of life Confirm the ph + ALL at molecular biology level Normal heart and lungs function Normal liver and kidney function Exclusion Criteria: Leukemia in the nervous system Recurrent patients Allergies associated with any drug in our research At the same time with other organs' malignant tumours participating in other clinical researches at the same time

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ph+ ALL with dasatinib<br>patients in the arm are newly diagnosed ph+ ALL,the patient first receive dexamethasone as pretreatment,then dasatinib and prednisone are used as inductive treatment,and methotrexate to consolidate the therapy. | Drug: Dasatinib<br>* 100mg (d1-d84)<br>* Other names: Sprycel;Drug: prednisone<br>* 60mg/m2 d1-24<br>* Other names: Pred;Drug: dexamethasone<br>* 10mg/d 3-7days<br>* Other names: Decadron;Drug: methotrexate<br>* 3g/m2 1day<br>* Other names: MTX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib |  | 115 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time needed to achieve MMR |  | 30 days |