Follicular Lymphoma
Conditions
Brief summary
A Phase Ib/III, Multicenter, double-blinded study of Parsaclisib, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma
Interventions
DRUGlenalidomide
lenalidomide is administered orally
DRUGrituximab
rituximab is administered intravenously
DRUGparsaclisib
parsaclisib is administered orally
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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) | 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
| 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 | 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 |
Outcome results
None listed