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

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

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Official title:

An Open-label and Single Arm Study of ATG-010 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03992339
• Other study ID #: ATG-010-DLBCL-001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 9, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2023
• Source: Antengene Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Chang chun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Chongqing Universtity Cancer Hospital	Chongqing	Chongqing
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Cancer Hospital of the University of the Chinese Academy of Sciences	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Province Cancer Hospital	Hefei	Anhui
China	The First Affilate Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Tianjin blood research institute	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Antengene Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Percentage of subjects with PR, or CR	6 months after the last subject was enrolled
Secondary	DOR	Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented	6 months after the last subject was enrolled
Secondary	DCR	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)	6 months after the last subject was enrolled
Secondary	OS	Duration of time from the first dose of study drug until death due to any cause	6 months after the last subject was enrolled
Secondary	PFS	Duration of time from the first dose of study drug until progression or death due to any cause	6 months after the last subject was enrolled