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Therapy with obinutuzumab for patients with lymphoma


- candidate number21835
- NTR NumberNTR5110
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mrt-2015
- Secondary IDsNL 48577.029.14  EUDRACT number 2013-004635-69
- Public TitleTherapy with obinutuzumab for patients with lymphoma
- Scientific TitleA phase II study of obinutuzumab monotherapy in rituximab-refractory follicular lymphoma
- ACRONYMZr-Obi
- hypothesisObinutuzumab can provide clinical benefit in patients with rituximab-refractory follicular lymphoma
- Healt Condition(s) or Problem(s) studiedRituximab-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 receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2015
- planned closingdate1-mei-2017
- Target number of participants25
- Interventionsobinutuzumab monotherapy given as 4 weekly infusions
- Primary outcome• Overall response rate using the Revised Response Criteria for Malignant Lymphoma (RRMCML) for disease assessment.
- Secondary outcome• Progression-free survival
• Overall survival
• Duration of response, in responders
• Duration of stable disease
• Time to next 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-PET
• The detection of 89Zr -obinutuzumab in normal tissue
• The description of safety data: all adverse and serious adverse events according to the NCICTCAE v.4.
- TimepointsResponse evaluation at week10-12 with FDG-PET/CT
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Y.W.S. Jauw
- CONTACT for SCIENTIFIC QUERIESDrs. Y.W.S. Jauw
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Roche
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD23-mrt-2015 - 26-apr-2015


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