Back to resultsIBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
Primary Purpose
Indolent Non-hodgkin Lymphoma
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
IBI376
Sponsored by
About this trial
This is an interventional treatment trial for Indolent Non-hodgkin Lymphoma focused on measuring Follicular Lymphoma, Marginal Zone Lymphoma, Parsaclisib
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years or older.
- Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a or MZL.
- Ineligible for hematopoietic stem cell transplant.
- Definition of RRFL or RRMZL: Subjects should have received 2 or more prior therapies for FL/MZL included at least one regimen containing Rituximab. Subjects should be refractory to Rituximab or experienced disease progression after achieved remission or disease progression within 6 months since last therapy.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
- Subjects must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- ECOG performance status 0 to 2.
- Life expectancy ≥ 12 weeks.
- Adequate hematologic, hepatic, and renal function.
- Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
1 . Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
2. History of central nervous system lymphoma (either primary or metastatic).
3. Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
4. Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
5. Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
6. Active graft-versus-host disease. 7. Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Sites / Locations
- Ruijin hospital, school of medicine, Shanghai jiao tong university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IBI376
Arm Description
IBI376 will be administered orally at a dose of 20 mg once daily for 8 weeks followed by 2.5 mg once daily.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
To assess the efficacy of IBI376 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL)/Marginal lymphoma(MZL). Subjects will be evaluated for ORR by an IRC (Lugano criteria)
Secondary Outcome Measures
Complete Response Rate (CRR)
To assess complete response rate (CRR)
Duration of Response (DOR)
To assess the duration of response (DOR)
Progression-free Survival (PFS)
To assess progression-free survival (PFS)
Overall Survival (OS)
To assess overall survival (OS)
Best percentage change in target lesion size
To assess best percentage change in target lesion size
Safety and tolerability of IBI376 measured by adverse events (AEs)
Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Full Information
NCT ID
NCT04298879
First Posted
March 2, 2020
Last Updated
March 13, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04298879
Brief Title
IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
Official Title
A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 7, 2020 (Actual)
Primary Completion Date
July 27, 2021 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
Detailed Description
Patients will be recruited for 2 cohorts. Cohort A will recruit 58 RRFL subjects, and Cohort B will recruit 62 RRMZL subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Non-hodgkin Lymphoma
Keywords
Follicular Lymphoma, Marginal Zone Lymphoma, Parsaclisib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBI376
Arm Type
Experimental
Arm Description
IBI376 will be administered orally at a dose of 20 mg once daily for 8 weeks followed by 2.5 mg once daily.
Intervention Type
Drug
Intervention Name(s)
IBI376
Other Intervention Name(s)
Parsaclisib
Intervention Description
IBI376 20 mg po. once daily for 8 weeks ，followed by 2.5mg once daily
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
To assess the efficacy of IBI376 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL)/Marginal lymphoma(MZL). Subjects will be evaluated for ORR by an IRC (Lugano criteria)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Complete Response Rate (CRR)
Description
To assess complete response rate (CRR)
Time Frame
2 years
Title
Duration of Response (DOR)
Description
To assess the duration of response (DOR)
Time Frame
2 years
Title
Progression-free Survival (PFS)
Description
To assess progression-free survival (PFS)
Time Frame
2 years
Title
Overall Survival (OS)
Description
To assess overall survival (OS)
Time Frame
2 years
Title
Best percentage change in target lesion size
Description
To assess best percentage change in target lesion size
Time Frame
2 years
Title
Safety and tolerability of IBI376 measured by adverse events (AEs)
Description
Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Time Frame
Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years or older.
Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a or MZL.
Ineligible for hematopoietic stem cell transplant.
Definition of RRFL or RRMZL: Subjects should have received 2 or more prior therapies for FL/MZL included at least one regimen containing Rituximab. Subjects should be refractory to Rituximab or experienced disease progression after achieved remission or disease progression within 6 months since last therapy.
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
Subjects must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
ECOG performance status 0 to 2.
Life expectancy ≥ 12 weeks.
Adequate hematologic, hepatic, and renal function.
Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
1 . Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
2. History of central nervous system lymphoma (either primary or metastatic).
3. Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
4. Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
5. Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
6. Active graft-versus-host disease. 7. Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
Facility Information:
Facility Name
Ruijin hospital, school of medicine, Shanghai jiao tong university
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
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