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

ph+ Acute Lymphoblastic Leukemia Clinical Trial

— TCLDCWTTNDPP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02690922
• Other study ID #: TJXYXXW
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 27, 2016
• Last updated: February 23, 2016
• Start date: March 2016
• Est. completion date: May 2017

Study information

• Verified date: February 2016
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Hubei Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• ph+ Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Dasatinib
100mg (d1-d84)
• prednisone
60mg/m2 d1-24
• dexamethasone
10mg/d 3-7days
• methotrexate
3g/m2 1day

Locations

Country	Name	City	State
China	Tongji hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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

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