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

Primary Purpose

ph+ Acute Lymphoblastic Leukemia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dasatinib
prednisone
dexamethasone
methotrexate
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ph+ Acute Lymphoblastic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tongji hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ph+ ALL with dasatinib

Arm 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.

Outcomes

Primary Outcome Measures

The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib

Secondary Outcome Measures

Time needed to achieve MMR

Full Information

First Posted
January 27, 2016
Last Updated
February 23, 2016
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02690922
Brief Title
Low-dose Chemotherapy Combine With Tyrosine Kinase Inhibitor to Treat ph+ Acute Lymphoblastic Leukemia Patients
Acronym
TCLDCWTTNDPP
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ph+ Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ph+ ALL with dasatinib
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
100mg (d1-d84)
Intervention Type
Drug
Intervention Name(s)
prednisone
Other Intervention Name(s)
Pred
Intervention Description
60mg/m2 d1-24
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
10mg/d 3-7days
Intervention Type
Drug
Intervention Name(s)
methotrexate
Other Intervention Name(s)
MTX
Intervention Description
3g/m2 1day
Primary Outcome Measure Information:
Title
The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib
Time Frame
115 days
Secondary Outcome Measure Information:
Title
Time needed to achieve MMR
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Get signed the informed consent of patients and family members Age ≥ 18 one full year of life Confirm the ph + ALL at molecular biology level Normal heart and lungs function Normal liver and kidney function Exclusion Criteria: Leukemia in the nervous system Recurrent patients Allergies associated with any drug in our research At the same time with other organs' malignant tumours participating in other clinical researches at the same time
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Meng, professor
Organizational Affiliation
Tongji Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24357015
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.
Results Reference
result

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

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