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A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma

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ClinicalTrials.gov Identifier: NCT03558412
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Mingzhi Zhang, Zhengzhou University

Brief Summary:
To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma.

Condition or disease Intervention/treatment Phase
T-lymphoblastic Lymphoma Combination Product: CODOX-M/IVAC Drug: Decitabine Phase 4

Detailed Description:
This is a prospective, open,investigator initial clinical trial with a single arm, aimed to evaluate the safety, tolerability, and efficacy of decitabine combined with Second-line chemotherapy regimens (CODOX-M/IVAC) in relapsed or refractory T-lymphoblastic lymphoma. A total of 40 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed or refractory T-lymphoblastic lymphoma will be treated with decitabine plus CODOX-M/IVAC. The primary end point is responder rate (RR) and time to progression (TTP), and the secondary end points include overall survival (OS) and the median survival time (MST).

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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: A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020


Arm Intervention/treatment
Experimental: 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.
Combination Product: CODOX-M/IVAC
Given ivgtt

Drug: Decitabine
Given ivgtt
Other Name: 5-Aza-2'-deoxycytidine




Primary Outcome Measures :
  1. RR [ Time Frame: up to 2 months ]
    Responder Rate

  2. TTP [ Time Frame: up to 2 months ]
    Time To Progression


Secondary Outcome Measures :
  1. OS [ Time Frame: up to 2 months ]
    Overall Survival

  2. MST [ Time Frame: up to 2 months ]
    Median Survival Time



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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age: 14~60 years; ECOG rate ≤ 2; expected survival > 3 months;
  • 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:

  • rejecting providing blood preparation;
  • 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.

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): NCT03558412


Contacts
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Contact: Mingzhi zhang, Pro,Dr 13838565629 Mingzhi_zhang@126.com
Contact: Mingzhi zhang 13838565629 Mingzhi_zhang@126.com

Locations
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China, Henan
Oncology Department of The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Mingzhi Zhang, Pro,Dr    13838565629    mingzhi_zhang@126.com   
Contact: Mingzhi Zhang, Pro,Drc    13838565629    mingzhi_zhang@126.com   
Sponsors and Collaborators
Mingzhi Zhang
Investigators
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Principal Investigator: Mingzhi zhang The First Affiliated Hospital of Zhengzhou University

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Responsible Party: Mingzhi Zhang, The director of oncology department of the first affiliated hospital, Zhengzhou University
ClinicalTrials.gov Identifier: NCT03558412     History of Changes
Other Study ID Numbers: hnslblzlzx20171118
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Mingzhi Zhang, Zhengzhou University:
Decitabine
RR
TTP
OS
MST

Additional relevant MeSH terms:
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Lymphoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors