A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma (TOUCH)

August 3, 2022 updated by: Antengene Corporation

A Single Arm, Open-label, and Multi-center Study to Evaluate the Safety and Primary Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Patients of Relapsed/Refractory Peripheral T- and NK/T-cell Lymphoma

This trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which will be chosen by investigators (ICE [ifosfamide+carboplatin+etoposide] or GEMOX [gemcitabine+oxaliplatin]), after treatments of 2 to 6 cycles transferring to ATG-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary efficacy of ATG-010 in R/R PTCL and NK/T-cell lymphoma patients.

Study Overview

Detailed Description

This trial is a single-arm, open-label, multi-center Phase Ib clinical study that will evaluate ATG-010 combined with chemotherapy regimen selected by investigators (ICE regimen ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin) sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in R/R PTCL and NK/T-cell lymphoma patients. Fifty patients are planned to be enrolled.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
          • Huiqiang Huang
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
          • Jianqiu Wu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Lei Fan
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • Jilin cancer hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical Universisity Cancer Institute & Hospital
        • Contact:
          • Huilai Zhang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
          • Zhen Cai

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The patient is willing to provide written ICF.
  2. Age≥ 18 years.
  3. R/R PTCL and NK/T-cell lymphoma as confirmed by histological methods according to WHO classification of tumors of lymphoid tissues 2016.
  4. Previously received at least one or more standard regimens including anthracycline.
  5. Recurrence or the recurrence disease after the last treatment completed.
  6. At least one measurable disease per modified efficacy assessment criteria (Cheson 2014).
  7. ECOG PS 0 or 1.
  8. Any toxicity caused by previously anti-tumor therapy must recovered to ≤ Grade 1 (NCI-CTCAE v5.0) with exception of hearing loss, alopecia, and pigmentation.
  9. Expected life time longer than 3 months.

Exclusion Criteria:

  1. Current have disease or history of central nervous system lymphoma.
  2. HBV-DNA positive, or HCV-RNA positive.
  3. Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
  4. Received major surgery within 4 weeks of first dose of study drug
  5. Known received SINE, including ATG-010.
  6. Unable to swallow the tablets, suffers from malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with ATG-010 absorption.
  7. Known allergy to ATG-010, or ICE, or GEMOX.
  8. A woman who is pregnant or nursing.
  9. The investigator considerations on patient's complications or other conditions may affect protocol compliance or may be inappropriate for participation in the study.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATG-010 + ICE
ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11

• Combined with ICE chemotherapy regimen:

  • Ifosfamide: 5 g/m2, continuous intravenous (iv) infusion (mesna 5 g/m2 synchronously iv infusion for rescue), on Day 2;
  • Carboplatin: with concentration-area under time curve (AUC)=5 (highest concentration to 800 mg), iv infusion, on Day 2;
  • Etoposide l00 mg/m2, iv infusion, on Days 1-3;
  • ATG-010 60 mg/once, oral, on Days 4 and 11. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).
Experimental: ATG-010 + GEMOX
ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9

• Combined with GEMOX chemotherapy regimen:

  • Gemcitabine 1000 mg/m2, iv infusion, on Days 1 and 8;
  • Oxaliplatin 130 mg/m2, iv infusion, on Day 1;
  • ATG-010 60 mg/once, oral, on Days 2 and 9. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AEs/SAEs
Time Frame: 18 months
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
18 months
Overall Response Rate (ORR)
Time Frame: 18 months
To determine the overall response rate according to Chenson 2014.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DOR)
Time Frame: 18 months
Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented.
18 months
Disease control rate (DCR)
Time Frame: 4 weeks to 18 months
Proportion of patients who achieve CR, PR, or SD for a minimum of 4 weeks, following the first dose of study drug (i.e., CR+PR+SD)
4 weeks to 18 months
Progression-free survival (PFS)
Time Frame: 18 months
Duration of time from the first dose of study drug until progression or death due to any cause
18 months
Overall Survival (OS)
Time Frame: 18 months
Duration of time from the first dose of study drug until death due to any cause
18 months

Collaborators and Investigators

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

Investigators

  • Study Director: Sai Lou, MD, Medical Director

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)

August 18, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

July 1, 2022

More Information

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.

Clinical Trials on Peripheral T-cell Lymphoma

Clinical Trials on ICE [ifosfamide+carboplatin+etoposide]

3
Subscribe