A Phase IIIb study of MabThera® (rituximab) maintenance therapy in patients with follicular Non-Hodgkin’s Lymphoma who have responded to induction therapy. - MAXIMA
- Conditions
- Follicular non Hodgkin's Lymphoma (NHL)
- Registration Number
- EUCTR2005-004977-12-FI
- Lead Sponsor
- F. Hoffmann-La Roche Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
1. Signed written informed consent form.
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 with a minimum of 8 cycles of rituximab (375 mg/m2 body surface area (BSA)) either as monotherapy, or combined with chemotherapy.
• 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 computerized tomography CT (or Positron Emission Tomography [PET] or Magnetic Resonance Imaging [MRI]) documented response to induction therapy: PR, CR or CRu. Response assessment must be made within six weeks of study entry.
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.
• If patients are recovering from chemotherapy related toxicity from the most recent rituximab-containing induction therapy, they may receive their first rituximab maintenance therapy 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 Eastern Cooperative Oncology Group (ECOG) scale.
8. Adequate haematological function within 28 days 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
• Platelet count = 100 x 109/L.
9. Patients must have 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.
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
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 < 20 mg/day prednisone.
7. Patients with prior or concomitant malignancies except non melanoma skin cancer or adequately treated in situ cervical cancer.
8. Major surgery (excluding lymph node biopsy) within 28 days prior to inclusion.
9. Poor hepatic function: total bilirubin > 2.0 mg/dL (34 µmol/L), alanine- and aspartate-amino-transferase (ALT, AST) > 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.
16. Treatment within a clinical study within 30 days prior to study entry.
17. Patient unable to provide informed consent or patients under protection from a guardian.
18. Active Infection requiring treatment, or chronic recurrent infection e.g. osteomyelitis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Progession 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) converstion 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
- Secondary Outcome Measures
Name Time Method