A PHASE I STUDY OF RO7030816 IN PATIENTS WITH B-CELL NON-HODGKIN'S LYMPHOMA
- Conditions
- B-cell non-Hodgkin's lymphoma, follicular lymphoma
- Registration Number
- JPRN-jRCT2080223801
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 68
[Dose-escalation cohorts]
- Histologically documented CD20+ B-cell NHL.
- Patients with r/r B-cell NHL and no other standard therapy(standard chemotherapy, autologous hematopoietic stem cell transplantation, etc.) that should be prioritized.
- ECOG PS of 0 or 1.
- Life expectancy more than 12 weeks from the date of enrollment.
- Major organ function meets all criteria.
[Expansion cohort]
- Histologically documented CD20+ Grade 1-3a relapsed or refractory FL.
- Patient received at least two prior systemic lymphoma therapy includinganti-CD20 targeted therapies and alkylating agents.
- ECOG PS of 0 or 1.
- Life expectancy more than 12 weeks from the date of enrollment.
- Major organ function meets all criteria.
[2L+ FL SC cohort]
- Histologically documented CD20+ Grade 1-3a relapsed or refractory FL.
- Patient received at least one prior systemic lymphoma therapy.
- ECOG PS of 0 to 2.
- Life expectancy more than 12 weeks from the date of enrollment.
- Major organ function meets all criteria.
- Previously untreated patients with FL must require systemic therapy assessed by investigator based on Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
[3L+ FL SC cohort]
- Histologically documented CD20+ Grade 1-3a relapsed or refractory FL.
- Patient received at least two prior systemic lymphoma therapy includinganti-CD20 targeted therapies and alkylating agents.
- ECOG PS of 0 to 2.
- Life expectancy more than 12 weeks from the date of enrollment.
- Major organ function meets all criteria.
[Dose-escalation cohorts, expansion cohort, 3L+ FL SC cohort]
- Pregnant or lactating woman.
- Current or previous autoimmune disease.
- Positive test result for human immunodeficiency virus antibody,hepatitis B surface antigen, HBs antibody, hepatitis B core antibody, or hepatitis C virus antibody.
- Current or previous clinically significant liver disease.
- Current central nervous system lymphoma, metastases to the CNS, or meningeal metastases.
- History of previous therapy with allogenic hematopoietic stem cell transplantation or solid organ transplantation.
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or fusion proteins.
[2L+ FL SC cohort]
- Pregnant or lactating woman.
- Current or previous autoimmune disease.
- Positive test result for human immunodeficiency virus antibody,hepatitis B surface antigen, HBs antibody, hepatitis B core antibody, or hepatitis C virus antibody.
- Current or previous clinically significant liver disease.
- Current central nervous system lymphoma, metastases to the CNS, or meningeal metastases.
- History of previous therapy with allogenic hematopoietic stem cell transplantation or solid organ transplantation.
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or fusion proteins.
- Patients at risk of hypersensitivity to lenalidomide and to excipients of lenalidomide
- Documented refractoriness to lenalidomide.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>other<br>NCI CTCAE, DLT, Revised Response Criteria for Malignant Lymphoma, Lugano response criteria
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>exploratory<br>pharmacokinetics<br>other<br>Revised Response Criteria for Malignant Lymphoma, Lugano response criteria, Endpoints other (ADA)