Main info

Identificatie:

HO55 NHL/MCL

Sponsor:

HOVON

Working group party:

Lymphoma

Age:

> 65

Stadium:

1st lijn

Included patients:

95

(of 95)

Active sites:

36

(of 30)

Title:

Efficacy of maintenance therapy with rituximab after induction chemotherapy (R-CHOP vs. R-FC) for elderly patients with mantle cell lymphoma not suitable for autologous stem cell transplantation

Timeline

News

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

• To test in elderly patients with advanced mantle cell lymphoma, whether rituximab plus a combination of fludarabine with cyclophosphamide (6 FC cycles) results in a higher reduction of lymphoma mass measured by the percentage of CR than rituximab combined with the standard chemotherapy scheme (8 CHOP

cycles).

• To compare maintenance therapy with rituximab with maintenance with interferon-alpha or pegylated interferon for progression free survival, after 2 different regimens of induction chemo-immunotherapy in elderly patients with

mantle cell lymphoma.

Eligibility

Inclusion Criteria:

• Histologically proven mantle cell lymphoma according to the WHO classification, preferably confirmed by central pathology review beforehand
• Clinical stage II, III or IV
• Previously untreated patients
• Above the age of 65 years and older or patients at the age between 60 and 65, if not eligible for high dose chemotherapy
• WHO performance ≤ 2
• Informed consent according to ICH/EU GCP and national/local regulations
• Measurable disease. If e.g. only BM infiltration, patients can only undergo a second randomization if a CR is obtained

Exclusion Criteria:

• WHO performance of 3 or more
• Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
• Leukocytes <2.0x 109/l or thrombocytes <100x 109/l, unless clearly related to MCL bone marrow infiltration
• Patients previously treated for lymphoma
• Patients without measurable lesions; if e.g. only bone marrow infiltration, patients may be included, but can only undergo a second randomization in case of CR
• Patients with stage I disease
• Patients with central nervous system involvement
• Patients with a history of autoimmune hemolytic anaemia or autoimmune trombocytopenia
• Patients with serious cardiac disease (uncontrolled arrhythmias, unstable angina, severe congestive heart failure)
• Patients with serious pulmonary, neurological, endocrinological or other disorder interfering with full dosing of CHOP or FC chemotherapy
• Liver enzymes >3x normal or bilirubin >2.5x normal (not due to lymphoma)
• Creatinine >2x normal value, corrected for age and weight (not due to lymphoma)
• Patients with unresolved hepatitis B or C infection or known HIV positive infection
• Uncontrolled infection
• Patients with a serious depression that needed therapy within the last 5 years
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Concomitant or previous malignancies other than basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease-free for at least 5 years

Registration Details

Participating Sites

= Active hospitals

= Inactive hospitals