Clinical trial NCT02690922: Low-dose Chemotherapy Combine With Tyrosine Kinase Inhibitor to Treat ph+ Acute Lymphoblastic Leukemia Patients
Official title: The Combination of Lower Dosage of Chemotherapy With Tyrosine Kinase Inhibitor to Treat Newly Diagnosed ph+ Acute Lymphoblastic Leukemia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ph+ Acute Lymphoblastic Leukemia
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib
timeFrame: 115 days
Secondary outcomes:
measure: Time needed to achieve MMR
timeFrame: 30 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Li Meng, professor
role: STUDY_CHAIR
References:
citation: Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.