IBI376 in Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04298879

Collaborator

(none)

120

Enrollment

Location

Arm

37.8

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Indolent Non-hodgkin Lymphoma	Drug: IBI376	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 7, 2020

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBI376 IBI376 will be administered orally at a dose of 20 mg once daily for 8 weeks followed by 2.5 mg once daily.	Drug: IBI376 IBI376 20 mg po. once daily for 8 weeks ，followed by 2.5mg once daily Other Names: Parsaclisib

Arm

Intervention/Treatment

Experimental: IBI376

IBI376 will be administered orally at a dose of 20 mg once daily for 8 weeks followed by 2.5 mg once daily.

Drug: IBI376

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

Other Names:

Parsaclisib

Outcome Measures

Primary Outcome Measures

Objective Response Rate (ORR) [2 years]
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) [2 years]
To assess complete response rate (CRR)
Duration of Response (DOR) [2 years]
To assess the duration of response (DOR)
Progression-free Survival (PFS) [2 years]
To assess progression-free survival (PFS)
Overall Survival (OS) [2 years]
To assess overall survival (OS)
Best percentage change in target lesion size [2 years]
To assess best percentage change in target lesion size
Safety and tolerability of IBI376 measured by adverse events (AEs) [Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject]
Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

History of central nervous system lymphoma (either primary or metastatic).
Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
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.
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.