A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT ID: NCT03992339

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-09
• Study Completion Date: 2023-12-01

Brief Summary

This is an open-label, single arm, and registered study of ATG-010 in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma.

Detailed Description

This is an open-label, single arm, and registered study. About 60 patients with relapsed/refractory DLBCL plan to be enrolled in about 10 study sites of the study. It is planned that at least 50% (~30 patients) will have the GCB subtype of DLBCL. Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. Patients should remain on the study treatment of ATG-010, until either PD or occurrence of unacceptable toxicity.

Conditions

Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATG-010

Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.

Group Type: EXPERIMENTAL

ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle

Intervention Type: DRUG

Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.

Interventions

ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle

Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.

Intervention Type: DRUG

Other Intervention Names

Selinexor

Eligibility Criteria

Inclusion Criteria

1. The patient must provide informed consent form (ICF) prior to the first screening procedure.

2. Age ≥18 years.

3. ECOG performance status of ≤ 2.

4. Patients should have estimated life expectancy of >3 months at study entry.

5. Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).

6. Patients must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL.

7. Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.

8. Patients must have measurable disease per the revised criteria for response assessment of lymphoma (Cheson, 2014).

9. Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue.

Exclusion Criteria

1. Patients who are pregnant or lactating.

2. DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma +NHL), or DLBCL transformed from diseases other than indolent NHL or Richter's.

3. Primary mediastinal (thymic) large B-cell lymphoma.

4. Known central nervous system lymphoma or meningeal involvement.

5. Patients whose most recent systemic anticancer therapy include radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids < 6 weeks prior to first dose of study drug.

6. Patients who have not recovered to Grade ≤ 1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy.

7. Patients with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation.

8. Major surgery within 2 weeks of first dose of study treatment of ATG-010.

9. Any life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.

10. Active hepatitis B virus or hepatitis C virus infection.

11. Known human immunodeficiency virus infection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antengene Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bingshan Liu, MD

Role: STUDY_DIRECTOR

Medical Monitor

Locations

Anhui Province Cancer Hospital

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Chongqing Universtity Cancer Hospital

Chongqing, Chongqing Municipality, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Wuhan Union Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affilate Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin blood research institute

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Cancer Hospital of the University of the Chinese Academy of Sciences

Hangzhou, Zhejiang, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ATG-010-DLBCL-001

Identifier Type: -

Identifier Source: org_study_id