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

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ClinicalTrials.gov Identifier: NCT02690922
Recruitment Status : Unknown
Verified February 2016 by Meng Li, Tongji Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Meng Li, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
ph+ Acute Lymphoblastic Leukemia Drug: Dasatinib Drug: prednisone Drug: dexamethasone Drug: methotrexate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Combination of Lower Dosage of Chemotherapy With Tyrosine Kinase Inhibitor to Treat Newly Diagnosed ph+ Acute Lymphoblastic Leukemia Patients
Study Start Date : March 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : May 2017


Arm Intervention/treatment
Experimental: ph+ ALL with dasatinib
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.
Drug: Dasatinib
100mg (d1-d84)
Other Name: Sprycel

Drug: prednisone
60mg/m2 d1-24
Other Name: Pred

Drug: dexamethasone
10mg/d 3-7days
Other Name: Decadron

Drug: methotrexate
3g/m2 1day
Other Name: MTX




Primary Outcome Measures :
  1. The rate of major molecular remission after two cycle chemotherapy with MTX and dasatinib [ Time Frame: 115 days ]

Secondary Outcome Measures :
  1. Time needed to achieve MMR [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690922


Locations
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China, Hubei
Tongji hospital Enrolling by invitation
Wuhan, Hubei, China, 430000
Sponsors and Collaborators
Tongji Hospital
Investigators
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Study Chair: Li Meng, professor Tongji Hospital

Publications of Results:
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Responsible Party: Meng Li, professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02690922     History of Changes
Other Study ID Numbers: TJXYXXW
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Prednisone
Methotrexate
Dasatinib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal