Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Parsaclisib+rituximab parsaclisib（2.5 mg QD，D1~D14/ per28 days）+rituximab ( 375mg/m2, IV, C1D1\D8\D15\D22, C2D1\C3D1\C4D1\C5D1). |
Drug: rituximab
rituximab is administered intravenously
Other Names:
Drug: parsaclisib
parsaclisib is administered orally
Other Names:
|
| Experimental: Parsaclisib+rituximab + lenalidomide 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: lenalidomide
lenalidomide is administered orally
Other Names:
Drug: rituximab
rituximab is administered intravenously
Other Names:
Drug: parsaclisib
parsaclisib is administered orally
Other Names:
|
Outcome Measures
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) [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 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 [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years old.
-
Histopathological diagnosis as FL Grade1, 2 or 3a
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The patient is not suitable or refuse the hematopoietic stem cell transplantation(HSCT).
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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.
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Life expectancy ≥12 weeks.
Exclusion criteria:
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Known histological transformation of diffuse large B-cell lymphoma (DLBCL) from indolent non-Hodgkin lymphoma (iNHL).
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A history of central nervous system lymphoma (primary or metastatic) and leptomeninges dease.
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Previously received Idelalisib, other selective PI3Kδ inhibitors or generic PI3K inhibitor treatment.
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Previously received Bruton tyrosine kinase inhibitors (e.g., ibrutinib).
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pregnant or lactating women.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin hospital, school of medicine, Shanghai jiao tong university Shanghai, China | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIBI376A301