NCT05867030

Brief Summary

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

Trial Health

45
At Risk

Trial Health Score

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

Timeline
85mo left

Started Jul 2023

Longer than P75 for phase_1

Status
withdrawn

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

Study Progress28%
Jul 2023Apr 2033

First Submitted

Initial submission to the registry

April 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 28, 2023

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2033

Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

6.1 years

First QC Date

April 10, 2023

Last Update Submit

October 15, 2023

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (3)

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

    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

    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.

    up to all subjects reached PFS endpoint, an average of 5 year

Secondary Outcomes (2)

  • 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

    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.

    Up to all subjects complete the study treatment, an average of 5 years

Study Arms (2)

Parsaclisib+rituximab

EXPERIMENTAL

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

Drug: rituximabDrug: parsaclisib

Parsaclisib+rituximab + lenalidomide

EXPERIMENTAL

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: lenalidomideDrug: rituximabDrug: parsaclisib

Interventions

lenalidomideDRUG

lenalidomide is administered orally

Also known as: Lainamei
Parsaclisib+rituximab + lenalidomide
rituximabDRUG

rituximab is administered intravenously

Also known as: Halpryza
Parsaclisib+rituximabParsaclisib+rituximab + lenalidomide
parsaclisibDRUG

parsaclisib is administered orally

Also known as: IBI376
Parsaclisib+rituximabParsaclisib+rituximab + lenalidomide

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

LenalidomideRituximabparsaclisib

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2023

First Posted

May 19, 2023

Study Start

July 28, 2023

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

April 30, 2033

Last Updated

October 17, 2023

Record last verified: 2023-10