Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Conditions
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.
Interventions
DRUGATG-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.
Sponsors
Antengene Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 12 months | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ATG-010 Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010.
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. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | ATG-010 |
|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 11.36 |
| Body Mass Index (BMI) | 23.94 kg/m^2 STANDARD_DEVIATION 3.089 |
| Race/Ethnicity, Customized Asian | 60 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 43 / 60 |
| other Total, other adverse events | 60 / 60 |
| serious Total, serious adverse events | 24 / 60 |
Outcome results
Primary
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.)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ATG-010 | ORR | 13 Participants |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ATG-010 | PFS | 1.87 month |