- HOVON 39 NHL / EORTC 20981
- Included patients:
- Active sites:
Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomised Clinical Trial & Intergroup Collaborative Study (EORTC 20981).
- Prospective randomized Phase III study
- Monitoring Type:
- Inclusion Criteria:
- Follicular NHL according to the REAL classification.
- Patients with Ann Arbor stages III or IV follicular NHL who have relapsed after a maximum of two adequate non-anthracycline containing systemic chemotherapy regimens.
- Patients with either remission (CR, PR), no change or progression on one of a maximum of 2 prior regiments.
- To qualify for remission or NC, duration of response c.q. NC upon one of the prior regimens should have been at least 4 weeks.
- Previous treatment should have been at least 2 months of single agent therapy and / or at least 2 consecutive cycles of polychemotherapy or purine analogues.
- The lymphoma must be CD20 positive.
- At least one mass should be present measurable by 2 perpendicular diameters by either physical or radiological examination.
- Age : 18 years or older.
- WHO Performance Status 0, 1 or 2.
- Patient information and written informed consent according to the rules of the respective country c.q institute.
Eligibility criteria for second randomisation:
- Patients in complete or partial remission at least 4 weeks after the last of 6 cycles of CHOP Mabthera.
- Patients in complete or partial remission at least 4 weeks after the last of at least 3 cycles of CHOP Mabthera, if this treatment had to be stopped because of CHOP-related adverse event.
- For patients treated with CHOP + Mabthera during remission induction: no Mabthera-related adverse event necessitating stopping of Mabthera administration.
- Time interval since last cycle of CHOP Mabthera between 4 and 8 weeks.
- IgG levels >= 3 gr/l.
- No active infection.
- Written informed consent.
- Exclusion Criteria:
- Prior treatment with more than two adequate regimens of systemic chemotherapy, or prior treatment with inadequate systemic chemotherapy.
- Prior treatment with anthracyclines / Mitoxantrone.
- Prior treatment with Mabthera.
- Circulating tumor cells > 10x109/l.
- Low grade lymphoma transformed into intermediate / high grade lymphoma.
- Patients with severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease.
- Serum creatinine, BUN, alkaline phosphatase or bilirubin: > 2.5 times the upper limit of the normal value, unless clearly related to NHL.
- Pregnant women.
- Patients with prior malignancies except non-melanoma skin tumors, stage 0 cervical carcinoma or curative surgical therapy longer than 5 years ago.
- Patients with known HIV positivity.
- Patients with symptomatic CNS lymphoma.
- Patients with bone marrow involvement only.
- Patients with uncontrolled asthma or allergy, requiring steroid treatment.
- Patients who are unable to attend regular outpatient appointments for treatment and treatment evaluation.
- Patients with IgG levels < 3 gr/l.
- Prior allogenic or autologous stem cell transplantation.
- Patients considered in near future for peripheral blood stem cell collection using chemotherapy for mobilisation.
- Patients known to have any hypersensitivity or anaphylactic reactions to murine proteins or to any component of this product.