Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

Follicular Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05867030
• Other study ID #: CIBI376A301
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 28, 2023
• Est. completion date: April 30, 2033

Study information

• Verified date: October 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2033
• Est. primary completion date: August 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 PI3Kd inhibitors or generic PI3K inhibitor treatment.

4. Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib).

5. pregnant or lactating women.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• lenalidomide
lenalidomide is administered orally
• rituximab
rituximab is administered intravenously
• parsaclisib
parsaclisib is administered orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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