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

Phase 2

Completed

Conditions: follicular lymphoma
lymphoma
10025320

Registration Number: NL-OMON41828

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

- biopsy -proven rituximab refractory follicular lymphoma
- no transformation to high grade or diffuse large B cell lymphoma
- radiographicaly documented measurable disease (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 cm).
- adult patients, older than 18 years
-ECOG performance score 0,1 or 2
-written informed consent according to GCP

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
-other active malignancy
-pregnant and breastfeeding women, and subjects of childbearing potential without adequate and effective contraception
- life expectancy less than 6 months
- active infectious disease (see protocol for definition)
- clinical significant cardiovascular disease
- abnormal laboratory values at screening (see protocol for definition)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is:<br /><br>* Overall response rate using the 'Lugano Classification 2014' for disease<br /><br>assessment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are:<br /><br>* Progression-free survival<br /><br>* Overall survival<br /><br>* Duration of response, in responders<br /><br>* Duration of stable disease<br /><br>* Time to next treatment<br /><br>* The detection of tumour lesions employing contrast enhanced CT-scan<br /><br>* The detection of tumour lesions employing 18F-FDG-PET<br /><br>* The detection of tumour lesions employing 89Zr -obinutuzumab-PET<br /><br>* The detection of 89Zr -obinutuzumab in normal tissue<br /><br>* The description of safety data: all adverse and serious adverse events<br /><br>according to the NCICTCAE v.4.</p><br>