NCT03558412

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

June 4, 2018

Last Update Submit

September 12, 2018

Conditions

T-lymphoblastic Lymphoma

Keywords

DecitabineRRTTPOSMST

Outcome Measures

Primary Outcomes (2)

  • RR

    Responder Rate

    up to 2 months

  • TTP

    Time To Progression

    up to 2 months

Secondary Outcomes (2)

  • OS

    up to 2 months

  • MST

    up to 2 months

Study Arms (1)

Arm A

EXPERIMENTAL

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/IVACDrug: Decitabine

Interventions

CODOX-M/IVACCOMBINATION_PRODUCT

Given ivgtt

Arm A
DecitabineDRUG

Given ivgtt

Also known as: 5-Aza-2'-deoxycytidine
Arm A

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Mingzhi zhang

    The First Affiliated Hospital of Zhengzhou University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingzhi zhang, Pro,Dr

CONTACT

13838565629Mingzhi_zhang@126.com

Mingzhi zhang

CONTACT

13838565629Mingzhi_zhang@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The director of oncology department of the first affiliated hospital

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 15, 2018

Study Start

June 1, 2018

Primary Completion

December 1, 2019

Study Completion

June 1, 2020

Last Updated

September 14, 2018

Record last verified: 2018-09

Locations

CN(1)