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

Tongji Hospital

Status and phase: Unknown; Phase 4

Conditions: ph+ Acute Lymphoblastic Leukemia

Treatments: Drug: Dasatinib; Drug: dexamethasone; Drug: prednisone; Drug: methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT02690922

TJXYXXW

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

ph+ ALL with dasatinib

Experimental group

Description:

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.

Treatment:

Drug: methotrexate

Drug: prednisone

Drug: dexamethasone

Drug: Dasatinib