A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma
NCT ID: NCT03558412
Last Updated: 2018-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2018-06-01
2020-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
Decitabine+CODOX-M/IVAC for patients with relapsed or refractory T-lymphoblastic lymphoma who used Hyper-CVAD or BFM-90 as first-line therapy:regimen A:CODOX-M:cyclophosphamide,epirubicin,vincristine,methotrexate.Regimen B :IVAC:ifosfamide,etoposide，cytarabine.Decitabine,10mg,ivgtt,used for 5 days before A+B.
CODOX-M/IVAC
Given ivgtt
Decitabine
Given ivgtt
Interventions
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CODOX-M/IVAC
Given ivgtt
Decitabine
Given ivgtt
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients with T-lymphoblastic lymphoma diagnosed by histopathology detection;
* patients ever received chemotherapy and/or radiotherapy;and can not be transplanted hematopoietic stem cells;
* patients with no chemotherapy contraindications: hemoglobin ≥ 90 g/L, absolute neutrophil count ≥1.5 x 109/L, blood platelet ≥100 x 109/L, ALT and AST ≤ 2-fold upper normal limit, serum bilirubin ≤ 1.5-fold upper normal limit, serum creatinine ≤ 1.5-fold upper normal limit, serum albumin ≥ 30 g/L, normal serofibrinogen;
* at least one measurable nidus;
* no other severe diseases conflict with this project, cardiopulmonary function is basically normal;
* the urine or blood pregnancy test of women in childbearing age must be negative in 7 days before follow-up visit;
* applicable for follow-up visit;
* no other antitumor adjoint therapy (including antitumor Chinese medicine, immunotherapy and biotherapy), but double phosphate anti-bone transfer therapy and other symptomatic treatment are acceptable;
* understanding this study and assigning informed consent.
Exclusion Criteria
* allergic to drug in this study and with metabolic block;
* rejecting adopting reliable contraceptive method in pregnancy or lactation period;
* uncontrolled internal medicine disease (including uncontrolled diabetes, severe incompetence cardiac, lung, liver and pancreas);
* with severe infection;
* with primary or secondary central nervous system tumor invasion;
* with immunotherapy or radiotherapy contraindication;
* ever suffered with malignant tumor;
* having peripheral nervous system disorder or dysphrenia;
* with no legal capacity, medical or ethical reasons affecting research proceeding;
* participating other clinical trials simultaneously;
* adopting other anti-tumor medicine excluding this research;
* the researchers considering it inappropriate to participate in the study.
14 Years
60 Years
ALL
No
Sponsors
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Mingzhi Zhang
OTHER
Responsible Party
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Mingzhi Zhang
The director of oncology department of the first affiliated hospital
Principal Investigators
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Mingzhi zhang
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Locations
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Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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hnslblzlzx20171118
Identifier Type: -
Identifier Source: org_study_id
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