Clinical trial NCT05867030: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Follicular Lymphoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of subjects with a complete response (CR) at the best overall response (BOR) assessed by the investigators (Complete Response Rate , CRR)
timeFrame: within 6 months after last patient enrolled, an average of 2 years
measure: 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
timeFrame: within 6 months after last patient enrolled, an average of 2 years
measure: 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.
timeFrame: up to all subjects reached PFS endpoint, an average of 5 year
Secondary outcomes:
measure: 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
timeFrame: within 12 months after last patient enrolled, an average of 2.5 years
measure: Percentage of subjects achieving CR or PR in the analysis population evaluated by IRC or investigator according to the Lugano 2014 criteria.
timeFrame: Up to all subjects complete the study treatment, an average of 5 years
Other outcomes:
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