IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma

Indolent Non-hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04298879
• Other study ID #: CIBI376A201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 7, 2020
• Est. completion date: June 2023

Study information

• Verified date: March 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma

Description:

Patients will be recruited for 2 cohorts. Cohort A will recruit 58 RRFL subjects, and Cohort B will recruit 62 RRMZL subjects.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 81
• Est. completion date: June 2023
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 years or older.

2. Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a or MZL.

3. Ineligible for hematopoietic stem cell transplant.

4. 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.

5. 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).

6. 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.

7. ECOG performance status 0 to 2.

8. Life expectancy = 12 weeks.

9. Adequate hematologic, hepatic, and renal function.

10. 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 PI3Kd 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.

Related Conditions & MeSH terms

• Indolent Non-hodgkin Lymphoma
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular

Intervention

Drug:
• IBI376
IBI376 20 mg po. once daily for 8 weeks ,followed by 2.5mg once daily

Locations

Country	Name	City	State
China	Ruijin hospital, school of medicine, Shanghai jiao tong university	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years
Secondary	Complete Response Rate (CRR)	To assess complete response rate (CRR)	2 years
Secondary	Duration of Response (DOR)	To assess the duration of response (DOR)	2 years
Secondary	Progression-free Survival (PFS)	To assess progression-free survival (PFS)	2 years
Secondary	Overall Survival (OS)	To assess overall survival (OS)	2 years
Secondary	Best percentage change in target lesion size	To assess best percentage change in target lesion size	2 years
Secondary	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.	Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject