Standard chemotherapy combination (Cyclophosphamide, Hydroxydaunorubicin, Vincristine, Prednisolone [CHOP]) with 1, 3 or 6 cycles of the monoclonal anti-CD20-antibody. Rituximab in first line therapy of follicular non-Hodgkin?s lymphoma.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN47525145

Enrollment

120

Registered

2006-01-06

Start date

2000-09-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Follicular Lymphoma World Health Organisation (WHO) Grade I and II, Stage 3-4 Cancer Lymphoma

Interventions

6 x CHOP + 1 x Rituximab versus 6 x CHOP + 3 x Rituximab versus 6 x CHOP + 6 x Rituximab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histologically proven CD20+ follicular lymphoma (follicular lymphoma grade I, II), stage III and IV 2. Age >18 years, no upper limit 3. No pre-treatment except irradiation and/or corticosteroids 4. Requirement of therapy: one or more of the following: B-symptoms, hematopoietic insufficiency (leukopenia 50% increase in sum of tumor diameters in six months); 'bulky disease' (mediastinal/abdominal tumor >7.5 cm and/or other lymphnodes >5 cm)

Exclusion criteria

Exclusion criteria: 1. Age 2 5. Pre-treatment with murine antibodies, severe organ impairment (heart, lung, neck) according to common criteria 6. Pre-treatment with any chemotherapy

Design outcomes

Primary

Measure	Time frame
Molecular remission rate after the end of six cycles of CHOP with various cycles of Rituximab antibodies, determined by t(14;18) real time PCR in peripheral blood and bone marrow.	—

Secondary

Measure	Time frame
1. Clinical remission rate 2. Duration of molecular and clinical response 3. Toxicity	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026