A phase II study of obinutuzumab monotherapy in rituximab-refractory follicular lymphoma

Phase 1

Active, not recruiting

• Conditions: rituximab refractory follicular lymphoma; MedDRA version: 16.1 Level: LLT Classification code 10016896 Term: Follicle centre lymphoma diffuse small cell lymphoma NOS System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-004635-69-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-26
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

•Biopsy-proven rituximab refractory follicular lymphoma (defined as disease progression while on rituximab maintenance therapy). Patients are required to have received a minimum of 2 infusions of rituximab maintenance therapy and/or be on a maintenance schedule for a minimum of 3 months (measured from the time of first maintenance infusion). Disease progression must have occurred before the last maintenance infusion.
•No clinical or pathological evidence of transformation to high-grade or diffuse large B-cell lymphoma (e.g. B symptoms, fast-growing tumour, or increasing lactate dehydrogenase level)
•Patients must have radiographically documented measurable disease, defined as 2 or more clearly demarcated lesions with a largest diameter of at least 1.5 cm or 1 clearly demarcated lesion with a largest diameter of at least 2.0 cm by computed tomography scan. All radiology studies must be performed within 14 days prior to registration.
•Adult patients, >=18 years of age
•Clinical indication for treatment as determined by the treating physician”
•ECOG performance status of 0, 1 or 2.
•Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
•Before patient registration, written informed consent must be given according to GCP, and national regulations.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Known central nervous system involvement
•Concurrent use of other anti-cancer agents
•All other lymphoma treatment (except rituximab maintenance therapy) during the last 6 months.
•Concurrent use of glucocorticoids (>10mg/day prednisolone or equivalent), or glucocorticoids (>10mg/day prednisolone or equivalent) within 4 weeks of first infusion
•Prior use of any investigational monoclonal antibody within 6 months of study start
•Prior use of any anti-cancer vaccine
•Previous allogeneic stem cell transplantation at any time or previous autologous stem cell transplantation within 6 months of first infusion
•More than 1 previous radioimmunotherapy
•Radioimmunotherapy within 3 months of first infusion
•Other active malignancy or history of other active malignancy. However patients who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
•Intolerance of exogenous protein administration
•Pregnant and breastfeeding women and those of childbearing potential who are not able or willing to use adequate and effective contraception.
Definition of adequate and effective contraception: use of two reliable forms of contraception.
For women, effective contraception is required to continue for = 12 months after the last dose of obinutuzumab. For men, effective contraception is required to continue for = 3 months after the last dose of obinutuzumab.
•Life expectancy < (less than) 6 months
•Clinical significant cardiovascular disease, such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina)
•Active infectious disease, requiring systemic treatment:
o Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B virus surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb] serology)
o Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing) Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA
o Vaccination with a live vaccine within 28 days prior to the start of study drug (Cycle 1, Day 1)
o Known HIV or HTLV-1 infection
•Any of the following abnormal laboratory values:
oCreatinine >1.5 times the upper limit of normal (unless creatinine clearance normal), or creatinine clearance <40 ml/min
oAspartate aminotransferase (AST) or alanine aminotransferase (ALT) ?>2.5 times the upper limit of normal
oTotal bilirubin >3 x ULN
oNeutrophil count <1.5 x 109/L (unless due to underlying disease, as established by extensive bone marrow involvement)
oHemoglobin <8 g/dL (unless due to underlying disease, as established by extensive bone marrow involvement)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified