ph+ Acute Lymphoblastic Leukemia Clinical Trial
— TCLDCWTTNDPPOfficial title:
The Combination of Lower Dosage of Chemotherapy With Tyrosine Kinase Inhibitor to Treat Newly Diagnosed ph+ Acute Lymphoblastic Leukemia Patients
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | May 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Tongji hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Tongji Hospital |
China,
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 chron — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib | 115 days | No | |
Secondary | Time needed to achieve MMR | 30 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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