Estudio en fase IIIb sobre el tratamiento de mantenimiento con MabThera® (rituximab) en pacientes con linfoma no hodgkiniano folicular que han respondido al tratamiento de inducción.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: infoma no Hodkiniano folicularFollicular non Hodgkin's Lymphoma (NHL)

• Registration Number: EUCTR2005-004977-12-ES
• Lead Sponsor: F. Hoffmann-La Roche Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-12
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Signed written informed consent form.
(For Germany see also Section 17.11.1)
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 with a minimum of 8 cycles of rituximab either as monotherapy, or combined with 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: PR, CR or 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 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. (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)
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

11. 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 other than a follicular non-Hodgkin’s lymphoma, except for non melanoma skin cancer, adequately treated in situ cervical cancer, or patients who have had previous cancers if they are considered cured and there has been no evidence of recurrence in the last 3 years.
8. Major surgery (excluding lymph node biopsy) within 28 days prior to their first rituximab maintenance infusion.
9. Poor hepatic function: total bilirubin > 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)
16. Treatment within a clinical study within 30 days prior to study entry.
(For Germany see also Section 17.11.1)
17. Patients unable to provide informed consent or patients under protection from a guardian.
(For Germany see also Section 17.11.1)
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