Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2SEARCHNCT03992339
A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
A Phase 2 study testing ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL), run by Antengene Corporation at 18 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- What is being tested?
- ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 18 sitesChina
- Study dates
- 9 Apr 2020to 1 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must provide informed consent form (ICF) prior to the first screening procedure.
- Age ≥18 years.
- ECOG performance status of ≤ 2.
- Patients should have estimated life expectancy of >3 months at study entry.
- Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
- 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.
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- Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
- Patients must have measurable disease per the revised criteria for response assessment of lymphoma (Cheson, 2014).
- Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue.
Who cannot join
- Patients who are pregnant or lactating.
- 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.
- Primary mediastinal (thymic) large B-cell lymphoma.
- Known central nervous system lymphoma or meningeal involvement.
- 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.
- Patients who have not recovered to Grade ≤ 1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy.
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- 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.
- Major surgery within 2 weeks of first dose of study treatment of ATG-010.
- Any life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
- Active hepatitis B virus or hepatitis C virus infection.
- Known human immunodeficiency virus infection.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021
Hunan Cancer Hospital
Changsha, Hunan, 410013
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Chongqing Universtity Cancer Hospital
Chongqing, Chongqing Municipality, 400000
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Cancer Hospital of the University of the Chinese Academy of Sciences
Hangzhou, Zhejiang, 310022
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Anhui Province Cancer Hospital
Hefei, Anhui, 230000
The First Affilate Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Tianjin blood research institute
Tianjin, Tianjin Municipality, 300052
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Hubei Cancer Hospital
Wuhan, Hubei, 430000
Wuhan Union Hospital
Wuhan, Hubei, 430022
Henan Cancer Hospital
Zhengzhou, Henan, 450003
About this study
Official title: An Open-label and Single Arm Study of ATG-010 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
This is an open-label, single arm, and registered study of ATG-010 in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma.
Read the 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.
- Being tested
- ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycleDrug
Also called Selinexor
Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.
| Study group | Role | What they receive |
|---|---|---|
| ATG-010 | Experimental | Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010. Receives: Drug: ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
ORR is defined as the proportion of patients who achieve either complete response (CR) or partial response (PR) according to the revised criteria for response assessment of lymphoma (2014 Lugano criteria: A complete metabolic response requires Score 1, 2, or 3 with or without a residual mass on 5PS(5-point scale using PET-CT). A PR requires a decrease by more than 50% in the sum of the product of the perpendicular diameters of up to six representative nodes or extranodal lesions.)
Measured: 12 months
Secondary outcomes (1)
PFS
PFS is defined as the duration from start of selinexor treatment to time of central imaging laboratory determined PD (based on 2014 Lugano criteria: Progressive metabolic disease requires Score 4 or 5 with an increase in intensity of uptake from baseline. Progressive disease by CT criteria only requires an increase in the PPDs of a single node by ≥ 50%.)or death from any cause, whichever occurs first.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start9 Apr 2020
- Primary completion31 May 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antengene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bingshan Liu, MD, Study director, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992339
- Sponsor's protocol ID
- ATG-010-DLBCL-001
- Acronym
- SEARCH
- Status last verified
- Apr 2024
- First submitted
- 18 Jun 2019
- Last updated
- 7 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label and Single Arm Study of ATG-010 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- ClinicalTrials.gov ID
- NCT03992339
- Acronym / sponsor ID
- SEARCH / ATG-010-DLBCL-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antengene CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 7 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATG-010 | Experimental | Drug: ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycleEnrolled patients will be treated with a fixed dose, 60 mg of ATG-010. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient must provide informed consent form (ICF) prior to the first screening procedure.
- Age ≥18 years.
- ECOG performance status of ≤ 2.
- Patients should have estimated life expectancy of >3 months at study entry.
- Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
Key exclusion criteria (11 listed)
- Patients who are pregnant or lactating.
- 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.
- Primary mediastinal (thymic) large B-cell lymphoma.
- Known central nervous system lymphoma or meningeal involvement.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycleAlso: SelinexorEnrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. | Drug | ATG-010 |
Primary outcome
ORR
Time frame: 12 months
ORR is defined as the proportion of patients who achieve either complete response (CR) or partial response (PR) according to the revised criteria for response assessment of lymphoma (2014 Lugano criteria: A complete metabolic response requires Score 1, 2, or 3 with or without a residual mass on 5PS(5-point scale using PET-CT). A PR requires a decrease by more than 50% in the sum of the product of the perpendicular diameters of up to six representative nodes or extranodal lesions.)
1 secondary outcome
PFS
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bingshan Liu, MD study director
Medical Monitor
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL), run by Antengene Corporation at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.