IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
Indolent Non-hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Indolent Non-hodgkin Lymphoma focused on measuring Follicular Lymphoma, Marginal Zone Lymphoma, Parsaclisib
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Ruijin hospital, school of medicine, Shanghai jiao tong university
Arms of the Study
Arm 1
Experimental
IBI376
IBI376 will be administered orally at a dose of 20 mg once daily for 8 weeks followed by 2.5 mg once daily.