Follicular non Hodgkin's Lymphoma (NHL)
Conditions
Interventions
Trade Name: MabThera
Product Name: MabThera
Product Code: RO045-2294
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Rituximab
CAS Number: 174722-31
Concentration unit
Sponsors
F. Hoffmann-La Roche Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be eligible for study entry: 1. Signed written informed consent form. (For Germany see also Section 17.11.1.1). 2. Histologically confirmed, CD20+, Grade 1, 2 or 3a follicular Non-Hodgkin’s lymphoma. 3. Patients must have received adequate induction therapy either as first line treatment or patients must have received adequate induction therapy as treatment for relapsed disease. • Adequate induction therapy is defined as treatment for a minimum of 8 cycles of rituximab either as monotherapy, or combined with induction chemotherapy. The time elapsed from the first to the last of the last 8 induction infusions should not exceed 30 weeks. • The type of chemotherapy and the number of cycles added to 8 cycles of rituximab is according to the investigator’s judgment (e.g., 6 x CVP + 8 x rituximab would be considered adequate for this study). 4. Patients must have a computerised tomography (CT) (or Positron Emission Tomography [PET] or Magnetic Resonance Imaging [MRI]) documented response to induction therapy: partial response (PR), complete response (CR) or unconfirmed complete response (CRu). Response assessment must be made within eight weeks of study entry. For lymphomas that cannot be measured by radiographic techniques (e.g. follicular lymphoma of the stomach) appropriate measurements replacing radiographic images need to be used (e.g. gastroscopy). 5. Induction therapy should have been completed to allow the first rituximab maintenance administration to occur eight to twelve weeks after day 1 of the last induction cycle (1 week before, or 2 weeks after, the period of eight to twelve weeks may be tolerated if these changes are due to documented administrative problems at the study site beyond the control of the site staff). • If patients are recovering from rituximab related toxicity from the most recent rituximab containing induction therapy, they may receive their first rituximab maintenance infusion up to six months after day 1 of the last cycle of induction therapy. 6. Patients must be = 18 years old. 7. Patients must have a performance status = 2 on the ECOG scale. 8. Adequate haematological function within 28 days prior to prior to their first rituximab maintenance infusion. This includes: • Haemoglobin = 8.0g/dL (5.0 mmol/L) • Absolute neutrophil count (ANC) = 1.5 x 109/L • Platelets count = 100 x 109/L. (Lower platelet counts [= 50 x 109/L] are acceptable if low level is due to toxicity of previous chemotherapy and not accompanied by bleeding.) 9. Patients must have immunoglobulin of type G (IgG) levels = 2g/L within 28 days prior to their first rituximab maintenance infusion. 10. Agree to use effective contraception, and agree not to become pregnant during participation in the study or within 12 months after the last rituximab maintenance infusion. Men agree not to father a child during participation in the study or within 12 months after the last rituximab maintenance infusion. (For Germany see also Section 17.11.1.1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with any of the following will be excluded from study entry: 1. Patients with poor compliance during induction therapy; judgment is up to investigators. 2. Patients who had significant delays / interruptions in their induction therapy such that completion of the planned rituximab therapy was more than four months longer than the planned schedule. 3. Stable disease (SD) or progressive disease (PD) after most recent induction therapy. 4. Transformation to high-grade lymphoma (secondary to “low grade” follicular lymphoma). 5. Presence or history of central nervous system (CNS) lymphomatous disease (e.g., CNS lymphoma or lymphomatous meningitis). 6. Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to 2.0 mg/dL (34 µmol/L), alanine-amino-transferase (ALT) > 3 x the upper limit of normal (ULN) unless these abnormalities are related to lymphoma. 10. Patients who have known Human Immuno-deficiency Virus (HIV) infection or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 11. Serious underlying medical conditions, which could impair the ability of the patient to participate in the study (e.g., uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease, uncontrolled hypertension or pre-existing cardiac condition). Judgment is up to the investigator. 12. Pregnant patients cannot enter the study. A negative serum pregnancy test is required for women of childbearing potential within seven days prior to first rituximab maintenance therapy infusion. 13. Breast-feeding patients are not permitted to enter the study. 14. Life expectancy of less than 6 months. 15. Known sensitivity or allergy to murine products. (For Germany see also Section 17.11.1.1) 16. Treatment within a clinical study within 30 days prior to study entry. (For Germany see also Section 17.11.1.1) 17. Patients unable to provide informed consent or patients under protection from a guardian. (For Germany see also Section 17.11.1.1) 18. Active infection requiring treatment, or chronic recurrent infection, e.g., osteomyelitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the safety of rituximab maintenance therapy following a rituximab-containing induction regimen in first line or relapsed patients with follicular Non-Hodgkin’s Lymphoma;Secondary Objective: to further confirm the effectiveness of rituximab maintenance therapy with respect to Progression Free Survival (PFS), Event Free Survival (EFS), Time to Next Lymphoma Treatment (TNLT), Overall survival (OS) and the partial response (PR) to complete response/complete response unconfirmed (CR/Cru) conversion rate while on rituximab maintenance therapy.;Primary end point(s): The primary endpoint of this study is safety. The following safety variables will be monitored during this study: AEs, laboratory tests and vital signs | — |
Countries
Finland, Germany, Greece, Italy, Slovakia, Slovenia, Spain, Sweden
Outcome results
None listed