Obinutuzumab plus bendamustine therapy in patients with relapsed follicular lymphoma: a single armed, multicentre, phase 2 trial

JRCT ID: jRCTs041190084

Registered date:22/11/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Follicular lymphoma
• Date of first enrollment: 10/03/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Obinutuzumab plus bendamustine therapy

Outcome(s)

• Primary Outcome: 3-year Progression Free Survival
• Secondary Outcome: overall survival, end of induction response, best overall response, adverse events, predictive markers of infection, secondary cancer, genetic analysis using formalin fixed paraffin embedded specimen and plasma

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Relapsed, histologically confirmed CD20-positive follicular lymphoma (Grades 1, 2, or 3A)
(2) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
(3) Aged 20 years or older at the time of informed consent
(4) Relapsed after one or two rituximab-containing chemotherapies
(5) Advanced stage follicular lymphoma at prior or second combination chemotherapies with Rituximab
(6) Rituximab sensitive
(7) If the participant has received prior Rituximab plus Bendamustine therapy, response duration must have been greater than 1 year without progression
(8) At least one bi-dimensionally measurable lesion on imaging scan(Measurable in two orthogonal directions with CT scan, and maximum diameter of the tumor is more than 1.5 cm
(9) Absolute neutrophil count (ANC) >= 1,000 /mm3 and platelets >= 75,000/mm3
(10) Patients who provided written informed consent

Exclude criteria

(1) Histologically proven or clinically suspected histological transformation
(2) Limited stage and meet criteria for low tumor burden at enrolment
(3) History of myocardial infarction within the last 6 months, or unstable angina
(4) Positive test results for chronic hepatitis B virus (HBV) infection and HBV-DNA 2.1 log copies/mL or more, or for hepatitis C virus (HCV) antibody, or human immunodeficiency virus andibody
(5) Evidence of laboratory abnormalities, aspartate aminotransferase or alanine aminotransferase concentration 100IU/L or more, total bilirubin 2.0mg/dl or more, or creatinine 2.0 mg/dl or more
(6) Women who are pregnant or who desire pregnant
(7) Prior history of malignancies, unless the patient has been free for at least 5 years
(8) Any serious medical condition, laboratory abnormality or psychiatric illness that the investigator or subinvestigator would judge inadequate to participate

Related Information

• Primary Sponsor: Hirokazu Nagai
• Source(s) of Monetary Support: Nippon Shinyaku Co., Ltd.,CHUGAI PHARMACEUTICAL CO., LTD.
• Secondary ID(s): ,