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

Primary Purpose

T-lymphoblastic Lymphoma

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

CODOX-M/IVAC

Decitabine

About this trial

This is an interventional treatment trial for T-lymphoblastic Lymphoma focused on measuring Decitabine, RR, TTP, OS, MST

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Oncology Department of The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

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.

Outcomes

Primary Outcome Measures

Responder Rate

TTP

Time To Progression

Secondary Outcome Measures

Overall Survival

MST

Median Survival Time

Full Information

NCT ID

NCT03558412

First Posted

June 4, 2018

Last Updated

September 12, 2018

Sponsor

Mingzhi Zhang

1. Study Identification

Unique Protocol Identification Number

NCT03558412

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

December 1, 2019 (Anticipated)

Study Completion Date

June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mingzhi Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

T-lymphoblastic Lymphoma

Keywords

Decitabine, RR, TTP, OS, MST

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

CODOX-M/IVAC

Intervention Description

Given ivgtt

Intervention Type

Drug

Intervention Name(s)

Decitabine

Other Intervention Name(s)

5-Aza-2'-deoxycytidine

Intervention Description

Given ivgtt

Primary Outcome Measure Information:

Title

Description

Responder Rate

Time Frame

up to 2 months

Title

TTP

Description

Time To Progression

Time Frame

up to 2 months

Secondary Outcome Measure Information:

Title

Description

Overall Survival

Time Frame

up to 2 months

Title

MST

Description

Median Survival Time

Time Frame

up to 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mingzhi zhang, Pro,Dr

Phone

13838565629

Mingzhi_zhang@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mingzhi zhang

Phone

13838565629

Mingzhi_zhang@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mingzhi zhang

Organizational Affiliation

The First Affiliated Hospital of Zhengzhou University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oncology Department of The First Affiliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Dr

Phone

13838565629

mingzhi_zhang@126.com

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Drc

Phone

13838565629

mingzhi_zhang@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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