NCT04298879

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

April 7, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2023

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

March 2, 2020

Last Update Submit

June 4, 2024

Conditions

Indolent Non-hodgkin Lymphoma

Keywords

Follicular LymphomaMarginal Zone LymphomaParsaclisib

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Complete Response Rate (CRR)

    2 years

  • Duration of Response (DOR)

    2 years

  • Progression-free Survival (PFS)

    2 years

  • Overall Survival (OS)

    2 years

  • Best percentage change in target lesion size

    2 years

  • +1 more secondary outcomes

Study Arms (1)

IBI376

EXPERIMENTAL

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

Interventions

IBI376DRUG

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

Also known as: Parsaclisib
IBI376

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital, school of medicine, Shanghai jiao tong university

Shanghai, China

Location

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, B-Cell, Marginal Zone

Interventions

parsaclisib

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 6, 2020

Study Start

April 7, 2020

Primary Completion

July 27, 2021

Study Completion

November 21, 2023

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations

CN(1)