JCOG2008: Obinutuzumab maintenance versus observation for patients with newly diagnosed high tumor burden follicular lymphoma who achieved complete metabolic response after obinutuzumab plus bendamustine induction therapy, a multicenter, randomized, phase III study

JRCT ID: jRCT1031210379

Registered date:20/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Untreated, advanced-stage high tumor burden follicular lymphoma
• Date of first enrollment: 26/10/2021
• Target sample size: 500
• Study type: Interventional

Intervention(s)

Induction therapy:OB therapy
Course 1
Obinutuzumab 1,000 mg/body (day 1,8,15)+Bendamustine 90 mg/m2 (day 1,2)
Course 2-6
Obinutuzumab 1,000 mg/body (day 1)+Bendamustine 90 mg/m2 (day 1,2), every 4 weeks

Maintenance therapy
Group A:Obinutuzumab maintenance therapy
Obinutuzumab 1,000 mg/body (day 1),every 8 weeks,12 cycles
Group B:observation
Patients receive follow-up observation

Outcome(s)

• Primary Outcome: PFS:progression-free survival

Secondary Outcome

OS:overall survival
TTNT:time to next treatment
POD24:progression of disease within 24 months
ORR:overall response rate
CRR:complete response rate
CMRR:complete metabolic response rate
adverse events
severe adverse events
histological/clinical transformation

Key inclusion & exclusion criteria

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

Include criteria

Primary registration criteria
(1) Follicular lymphoma (Grade1, 2 or 3A) with CD20 positive.
(2) Ann Arbor CS II, III or IV diagnosed by CT and bone marrow examination.
(3) Any of the following (i) to (viii) are fulfilled by physical findings and CT within 56 days before entry
(i) Largest nodal or extra nodal mass more than 7cm
(ii) More then three nodal sites with a diameter of 3cm or more
(iii) Lymphoma cell in peripheral blood more than 5000/mm3
(iv) The presence of B symptoms
(v) Spleen size is more than 16cm by CT
(vi) Massive serous effusions
(vii) Critical organ compression
(viii) Cytopenia due to lymphomatous bone marrow involvement(fullfills one or more of the following three)
Absolute neutrophil count < 1000/mm3
Hemoglobin concentration < 10 g/dL
Absolute platelet count < 100000/mm3
(4) Aged 20 or older
(5) ECOG performance status (PS) of 0 to 2
(6) Measurable lesions
(7) No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
(8) Patients with sufficient organ functions
(9) Written informed consent

Secondary registration criteria
(1) Primary registration for this trial
(2) Following (i) or (ii) is satisfied.
(i)OB therapy (6 courses) was completed and CMR was obtained by FDG-PET/ CT
(ii)OB therapy (only 4 or 5 courses) was completed due to adverse events and CMR was obtained by FDG-PET/CT
(3)No Grade 2 or higher non-hematological toxicity
(4)ECOG performance status (PS) of 0 to 1
(5)Patients with sufficient organ functions
(6)Within 42-98 days from the last administration of OB therapy

Exclude criteria

(1) Synchronous double or multiple cancer or metachronous double or multiple cancer with progression free period less than 5 years.
(2) Infectious disease requiring systemic treatment.
(3) A fever over 38 degrees (except when infection or drug fever can be ruled out)
(4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy.
(5) Severe psychological disorder.
(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
(7) Uncontrollable diabetes mellitus
(8) Uncontrollable hypertension
(9) Unstable angina pectoris, or history of myocardial infarction within six months.
(10) HBs-Ag positive or HCV-Ab positive
(11) HBs-Ab positive or HBc-Ab positive with HBV DNA levels of 20 IU/mL (1.3 logIU/mL) or more
(12) Positive HIV antibody

Related Information

• Primary Sponsor: FUKUHARA Noriko
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development