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

T-lymphoblastic Lymphoma Clinical Trial

Official title:

A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03558412
• Other study ID #: hnslblzlzx20171118
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• T-lymphoblastic Lymphoma

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