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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41828

Enrollment

Registered

2014-03-26

Start date

2015-08-19

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

follicular lymphoma lymphoma

Interventions

Induction I: treatment with obinutuzumab: - week 1day 0 (100mg) - week 1 day 1 (900 mg) + 10mg 89Zr-obinutuzumab - week 2 day 1(1000mg) - week 3 day 1 (1000mg) - week 4 day 1 (1000mg) For patients w

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
The primary endpoint is: * Overall response rate using the 'Lugano Classification 2014' for disease assessment.	—

Secondary

Measure	Time frame
The secondary endpoints are: * 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.	—

Measure

Time frame

The secondary endpoints are: * 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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)