Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

October 15, 2023 updated by: Innovent Biologics (Suzhou) Co. Ltd.

A Phase Ib/III Study to Evaluating the Efficacy and Safety of Parsaclisib in Combination With Rituximab and Lenalidomide Versus Rituximab in Combination With Lenalidomide in Subjects With Relapsed or Refractory Follicular Lymphoma

A Phase Ib/III, Multicenter, double-blinded study of Parsaclisib, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin hospital, school of medicine, Shanghai jiao tong university Shanghai, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years old.
  2. Histopathological diagnosis as FL Grade1, 2 or 3a
  3. The patient is not suitable or refuse the hematopoietic stem cell transplantation(HSCT).
  4. Presence of radiographically measurable lymph nodes or extranodal lesions, defined as at least one lesion longest diameter (LD) measurements > 1.5 cm and longest vertical diameter (LPD) measurements ≥1.0 cm.
  5. Life expectancy ≥12 weeks.

Exclusion criteria:

  1. Known histological transformation of diffuse large B-cell lymphoma (DLBCL) from indolent non-Hodgkin lymphoma (iNHL).
  2. A history of central nervous system lymphoma (primary or metastatic) and leptomeninges dease.
  3. Previously received Idelalisib, other selective PI3Kδ inhibitors or generic PI3K inhibitor treatment.
  4. Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib).
  5. pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parsaclisib+rituximab
parsaclisib（2.5 mg QD，D1~D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\D8\D15\D22, C2D1\C3D1\C4D1\C5D1).
Drug: rituximab
rituximab is administered intravenously
Other Names:
  • Halpryza
Drug: parsaclisib
parsaclisib is administered orally
Other Names:
  • IBI376
Experimental: Parsaclisib+rituximab + lenalidomide
parsaclisib（2.5 mg QD，D1~D14/ per28 days）+rituximab( 375mg/m2, IV, C1D1\D8\D15\D22, C2D1\C3D1\C4D1\C5D1)+lenalidomide( 20mg PO, D1-D21/Cycle, no more than 12cycles).
Drug: rituximab
rituximab is administered intravenously
Other Names:
  • Halpryza
Drug: parsaclisib
parsaclisib is administered orally
Other Names:
  • IBI376
Drug: lenalidomide
lenalidomide is administered orally
Other Names:
  • Lainamei

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with a complete response (CR) at the best overall response (BOR) assessed by the investigators (Complete Response Rate , CRR)
Time Frame: within 6 months after last patient enrolled, an average of 2 years
within 6 months after last patient enrolled, an average of 2 years
The incidence of treatment-emergent adverse event (TEAE) and the incidence of adverse events of special interest (AESI) leading to permanent discontinuation and/or dose-reduction
Time Frame: within 6 months after last patient enrolled, an average of 2 years
within 6 months after last patient enrolled, an average of 2 years
The duration from randomization to disease progression as assessed by an Independent Evaluation Committee (IRC) according to the revised Lymphoma Response Evaluation Criteria (Lugano 2014 criteria) or all-cause death.
Time Frame: up to all subjects reached PFS endpoint, an average of 5 year
up to all subjects reached PFS endpoint, an average of 5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of treatment-emergent adverse event (TEAE) and the incidence of adverse events of special interest (AESI) leading to permanent discontinuation and/or dose-reduction
Time Frame: within 12 months after last patient enrolled, an average of 2.5 years
within 12 months after last patient enrolled, an average of 2.5 years
Percentage of subjects achieving CR or PR in the analysis population evaluated by IRC or investigator according to the Lugano 2014 criteria.
Time Frame: Up to all subjects complete the study treatment, an average of 5 years
Up to all subjects complete the study treatment, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 28, 2023

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

April 30, 2033

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 15, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBI376A301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Follicular Lymphoma

Clinical Trials on rituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe