IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
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|ClinicalTrials.gov Identifier: NCT04298879|
Recruitment Status : Active, not recruiting
First Posted : March 6, 2020
Last Update Posted : March 14, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Indolent Non-hodgkin Lymphoma||Drug: IBI376||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma|
|Actual Study Start Date :||April 7, 2020|
|Actual Primary Completion Date :||July 27, 2021|
|Estimated Study Completion Date :||June 2023|
IBI376 will be administered orally at a dose of 20 mg once daily for 8 weeks followed by 2.5 mg once daily.
IBI376 20 mg po. once daily for 8 weeks ，followed by 2.5mg once daily
Other Name: Parsaclisib
- Objective Response Rate (ORR) [ Time Frame: 2 years ]To assess the efficacy of IBI376 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL)/Marginal lymphoma(MZL). Subjects will be evaluated for ORR by an IRC (Lugano criteria)
- Complete Response Rate (CRR) [ Time Frame: 2 years ]To assess complete response rate (CRR)
- Duration of Response (DOR) [ Time Frame: 2 years ]To assess the duration of response (DOR)
- Progression-free Survival (PFS) [ Time Frame: 2 years ]To assess progression-free survival (PFS)
- Overall Survival (OS) [ Time Frame: 2 years ]To assess overall survival (OS)
- Best percentage change in target lesion size [ Time Frame: 2 years ]To assess best percentage change in target lesion size
- Safety and tolerability of IBI376 measured by adverse events (AEs) [ Time Frame: Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject ]Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Aged 18 years or older.
- Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a or MZL.
- Ineligible for hematopoietic stem cell transplant.
- Definition of RRFL or RRMZL: Subjects should have received 2 or more prior therapies for FL/MZL included at least one regimen containing Rituximab. Subjects should be refractory to Rituximab or experienced disease progression after achieved remission or disease progression within 6 months since last therapy.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
- Subjects must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- ECOG performance status 0 to 2.
- Life expectancy ≥ 12 weeks.
- Adequate hematologic, hepatic, and renal function.
- Willingness to avoid pregnancy or fathering children.
1 . Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
2. History of central nervous system lymphoma (either primary or metastatic).
3. Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.
4. Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
5. Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
6. Active graft-versus-host disease. 7. Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04298879
|Ruijin hospital, school of medicine, Shanghai jiao tong university|
|Responsible Party:||Innovent Biologics (Suzhou) Co. Ltd.|
|Other Study ID Numbers:||
|First Posted:||March 6, 2020 Key Record Dates|
|Last Update Posted:||March 14, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Marginal Zone Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Immune System Diseases