Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects

December 30, 2021 updated by: WEI XU, The First Affiliated Hospital with Nanjing Medical University

A Phase 2 Study Evaluating Efficacy and Safety of Chi-BEAC Combining With Auto-HSCT to Treat Aggressive Lymphoma Subjects

This is a single arm, multi-center, open study to evaluating efficacy and safety of Chi-BEAC combining with auto-HSCT to treat aggressive lymphoma Subjects

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Hematological Department, People's Hospital of Jiangsu Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aggressive lymphoma subjects: diffuse large B cell lymphoma confirmed by immunohistochemistry, aaIPI≥2 or double-hit lymphoma, as first-line consolidation; diffuse large B cell lymphoma as second-line consolidation therapy; peripheral T-cell lymphoma except ALK-positive type, as first-line or second-line consolidation therapy; mantle cell lymphoma, as first-line or second-line consolidation therapy.

  2. Adequate organ system function including:

    Creatinine clearance rate ≥ 80ml/min and creatinine < 160μmol/L ALT/AST ≤ 2 upper limit of normal Total Bilirubin < 2 upper limit of normal FEV1、FVC and DLCO ≥ 50% predictive value Left ventricular ejection fraction ≥ 50% No Symptomatic arrhythmia

  3. Age 18-60 years, male and female
  4. ECOG score 0-1
  5. Number of neutrophil ≥ 1.5×10^9/L, number of platelet ≥ 70×10^9/L, concentration of hemoglobin ≥ 90g/L, number of CD34+ cells ≥ 2.0×10^6/kg
  6. Expected survival ≥ 12 weeks
  7. Volunteered to participate in this study and signed informed consent

Exclusion Criteria:

  1. Have evidence of CNS lymphoma
  2. Relapse after autologous hematopoietic stem cell transplantation
  3. Active hepatitis B or hepatitis C virus infection
  4. Severe active infection
  5. HIV-infected persons
  6. Liver cirrhosis or hepatic fibrosis
  7. QTc > 500ms
  8. Have mental disorder or unable to sign informed consent
  9. History of drug abuse and intemperance
  10. Women who are pregnant or lactating or have breeding intent
  11. The investigators believe that any increase in the risk of the subject or interference with the results of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival rate
Time Frame: 2 years after transplantation
2 years after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years after transplantation
2 years after transplantation
Complete remission
Time Frame: 3 months after transplantation
3 months after transplantation
Time of hematopoietic reconstitution
Time Frame: 15 days, 1 month
15 days, 1 month
Non-relapse mortality
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 5, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSPH-Chi-BEAC-HSCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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