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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03558412
Other study ID # hnslblzlzx20171118
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2018
Est. completion date June 1, 2020

Study information

Verified date September 2018
Source Zhengzhou University
Contact Mingzhi zhang, Pro,Dr
Phone 13838565629
Email Mingzhi_zhang@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 1, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
CODOX-M/IVAC
Given ivgtt
Drug:
Decitabine
Given ivgtt

Locations

Country Name City State
China Oncology Department of The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Mingzhi Zhang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary RR Responder Rate up to 2 months
Primary TTP Time To Progression up to 2 months
Secondary OS Overall Survival up to 2 months
Secondary MST Median Survival Time up to 2 months
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