Main info

Identificatie:

HOVON 39 NHL / EORTC 20981

Sponsor:

HOVON

Included patients:

465

Active sites:

31

(of 33)

Title:

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).

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

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.

Participating Sites

= Active hospitals

= Inactive hospitals