|- candidate number||21948|
|- NTR Number||NTR5317|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-apr-2015|
|- Secondary IDs||NL 48577.029.14 EUDRACT number 2013-004635-69|
|- Public Title||Therapy with obinutuzumab for patients with lymphoma|
|- Scientific Title||A phase II study of obinutuzumab monotherapy in rituximab-refractory follicular lymphoma|
|- hypothesis||Obinutuzumab can provide clinical benefit in patients with rituximab-refractory follicular lymphoma|
|- Healt Condition(s) or Problem(s) studied||Rituximab-refractory follicular lymphoma |
|- 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.
|- 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:
o Creatinine 1.5 times the upper limit of normal (unless creatinine clearance normal), or creatinine clearance 40 ml/min
o Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2.5 times the upper limit of normal
o Total bilirubin 3 ULN
o Neutrophil count 1.5 109/L (unless due to underlying disease, as established by extensive bone marrow involvement)
o Hemoglobin 8 g/dL (unless due to underlying disease, as established by extensive bone marrow involvement)
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||4-mei-2015|
|- planned closingdate||4-jun-2017|
|- Target number of participants||25|
|- Interventions||obinutuzumab monotherapy given as 4 weekly infusions|
|- Primary outcome|| Overall response using the Revised Response Criteria for Malignant Lymphoma (RRMCML) for disease assessment (10)|
|- Secondary outcome|| Progression-free survival|
Duration of response, in responders
Duration of stable disease
Time to next anti-lymphoma treatment
The detection of tumour lesions employing contrast enhanced CT-scan
The detection of tumour lesions employing 18F-FDG-PET
The detection of tumour lesions employing 89Zr-obinutuzumab immuno-PET
The detection of 89Zr-obinutuzumab in normal tissue
The description of safety data: all adverse events and serious adverse events (AEs/SAEs) according to to the NCI CTCAE v.4.
|- Timepoints||Response evaluation at week10-12 with FDG-PET/CT|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. Y.W.S. Jauw|
|- CONTACT for SCIENTIFIC QUERIES|| J.M. Zijlstra|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||15-apr-2015 - 24-aug-2015|