Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma
NCT ID: NCT05867030
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2023-07-28
2033-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Parsaclisib+rituximab
parsaclisib(2.5 mg QD,D1\~D14/ per28 days)+rituximab ( 375mg/m2, IV, C1D1\\D8\\D15\\D22, C2D1\\C3D1\\C4D1\\C5D1).
rituximab
rituximab is administered intravenously
parsaclisib
parsaclisib is administered orally
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).
lenalidomide
lenalidomide is administered orally
rituximab
rituximab is administered intravenously
parsaclisib
parsaclisib is administered orally
Interventions
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lenalidomide
lenalidomide is administered orally
rituximab
rituximab is administered intravenously
parsaclisib
parsaclisib is administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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CIBI376A301
Identifier Type: -
Identifier Source: org_study_id
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