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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-05-31

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.

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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.

Conditions

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ph+ Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ph+ ALL with dasatinib

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.

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

100mg (d1-d84)

prednisone

Intervention Type DRUG

60mg/m2 d1-24

dexamethasone

Intervention Type DRUG

10mg/d 3-7days

methotrexate

Intervention Type DRUG

3g/m2 1day

Interventions

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Dasatinib

100mg (d1-d84)

Intervention Type DRUG

prednisone

60mg/m2 d1-24

Intervention Type DRUG

dexamethasone

10mg/d 3-7days

Intervention Type DRUG

methotrexate

3g/m2 1day

Intervention Type DRUG

Other Intervention Names

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Sprycel Pred Decadron MTX

Eligibility Criteria

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Inclusion Criteria

1. Get signed the informed consent of patients and family members
2. Age ≥ 18 one full year of life
3. Confirm the ph + ALL at molecular biology level
4. Normal heart and lungs function
5. Normal liver and kidney function

Exclusion Criteria

1. Leukemia in the nervous system
2. Recurrent patients
3. Allergies associated with any drug in our research
4. At the same time with other organs' malignant tumours
5. participating in other clinical researches at the same time

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No