Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

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Primary Purpose

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

lenalidomide

rituximab

parsaclisib

About this trial

This is an interventional treatment trial for Follicular Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years old. Histopathological diagnosis as FL Grade1, 2 or 3a The patient is not suitable or refuse the hematopoietic stem cell transplantation(HSCT). 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. Life expectancy ≥12 weeks. Exclusion criteria: Known histological transformation of diffuse large B-cell lymphoma (DLBCL) from indolent non-Hodgkin lymphoma (iNHL). A history of central nervous system lymphoma (primary or metastatic) and leptomeninges dease. Previously received Idelalisib, other selective PI3Kδ inhibitors or generic PI3K inhibitor treatment. Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib). pregnant or lactating women.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Parsaclisib+rituximab

Parsaclisib+rituximab + lenalidomide

Arm Description

parsaclisib（2.5 mg QD，D1~D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\D8\D15\D22, C2D1\C3D1\C4D1\C5D1).

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).

Outcomes

Primary Outcome Measures

Percentage of subjects with a complete response (CR) at the best overall response (BOR) assessed by the investigators (Complete Response Rate , CRR)

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

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.

Secondary Outcome Measures

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

Percentage of subjects achieving CR or PR in the analysis population evaluated by IRC or investigator according to the Lugano 2014 criteria.

Full Information

NCT ID

NCT05867030

First Posted

April 10, 2023

Last Updated

October 15, 2023

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05867030

Brief Title

Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Development strategy adjustment

Study Start Date

July 28, 2023 (Anticipated)

Primary Completion Date

August 31, 2029 (Anticipated)

Study Completion Date

April 30, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Follicular Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Parsaclisib+rituximab

Arm Type

Experimental

Arm Description

parsaclisib（2.5 mg QD，D1~D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\D8\D15\D22, C2D1\C3D1\C4D1\C5D1).

Arm Title

Parsaclisib+rituximab + lenalidomide

Arm Type

Experimental

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

lenalidomide

Other Intervention Name(s)

Lainamei

Intervention Description

lenalidomide is administered orally

Intervention Type

Drug

Intervention Name(s)

rituximab

Other Intervention Name(s)

Halpryza

Intervention Description

rituximab is administered intravenously

Intervention Type

Drug

Intervention Name(s)

parsaclisib

Other Intervention Name(s)

IBI376

Intervention Description

parsaclisib is administered orally

Primary Outcome Measure Information:

Title

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

Title

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

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age ≥18 years old. Histopathological diagnosis as FL Grade1, 2 or 3a The patient is not suitable or refuse the hematopoietic stem cell transplantation(HSCT). 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. Life expectancy ≥12 weeks. Exclusion criteria: Known histological transformation of diffuse large B-cell lymphoma (DLBCL) from indolent non-Hodgkin lymphoma (iNHL). A history of central nervous system lymphoma (primary or metastatic) and leptomeninges dease. Previously received Idelalisib, other selective PI3Kδ inhibitors or generic PI3K inhibitor treatment. Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib). pregnant or lactating women.

Follicular Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial