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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02690922
Acronym
TCLDCWTTNDPP
Enrollment
40
Registered
2016-02-24
Start date
2016-03-31
Completion date
2017-05-31
Last updated
2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ph+ Acute Lymphoblastic Leukemia

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.

Interventions

DRUGDasatinib

100mg (d1-d84)

DRUGprednisone

60mg/m2 d1-24

DRUGdexamethasone

10mg/d 3-7days

DRUGmethotrexate

3g/m2 1day

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib115 days

Secondary

MeasureTime frame
Time needed to achieve MMR30 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026