Status:
COMPLETED
IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Indolent Non-hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04298879
Start Date
April 7 2020
End Date
November 21 2023
Last Update
June 5 2024
Active Locations (1)
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1
Ruijin hospital, school of medicine, Shanghai jiao tong university
Shanghai, China