Clinical trial NCT03992339: A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Official title: An Open-label and Single Arm Study of ATG-010 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Lead sponsor: Antengene Corporation
Sponsor class: INDUSTRY
First posted: 2019-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: ORR
timeFrame: 12 months
Secondary outcomes:
measure: PFS
timeFrame: 12 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Province Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing Universtity Cancer Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: The First Affilate Hospital with Nanjing Medical University
state: Jiangsu
city: Chang chun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin blood research institute
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Cancer Hospital of the University of the Chinese Academy of Sciences
state: Zhejiang
Study officials:
affiliation: Medical Monitor
name: Bingshan Liu, MD
role: STUDY_DIRECTOR
References: