Safety and efficacy study in patients with untreated follicular non-Hodgkin´s lymphoma.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 530

Inclusion Criteria

- Male or female patients, at least 18 years of age at Screening.
- Untreated, histologically confirmed, stage III or IV NHL (CD20+ Follicular Lymphoma of Grade 1, 2 or 3a, requiring chemotherapy).
- Patients not previously treated. Eligible patients previously on watch and wait (i.e., those patients who do not require treatment upfront at the time of the diagnosis) can enter the trial.
- ECOG performance status of 0 to 2.
- Have at least one measurable lesion as per the IWG criteria 2007 at Screening.
- Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) within 28 days prior to randomization, including:
• Hemoglobin = 9.0 g/dL (= 5.6 mmol/L).
• Absolute neutrophil count = 1.5 x 109/L.
• Platelet count = 100 x 109/L.
- Adequate renal and liver function
- For participants of reproductive potential (males and females), use of a medically acceptable method of contraception during the trial.
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 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

Exclusion Criteria

- Transformation to high-grade lymphoma (secondary to low grade lymphoma).
- Presence or history of central nervous system (CNS) lymphoma.
- Patients receiving current treatment with oral corticosteroids must not be receiving a dose exceeding 20 mg/day prednisone or equivalent.
- Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, idarubicin and/or other anthracyclines and anthracenediones.
- Patients with prior or concomitant malignancies.
- Major surgery (excluding lymph node biopsy) within 28 days prior to randomization.
- Poor renal function: serum creatinine > 2.0 mg/dL (> 197 mcmol/L).
- Poor hepatic function: total bilirubin > 2.0 mg/dL (> 34 mcmol/L) or aspartate aminotransferase (AST) > 3 times the upper limit of normal.
- Active, chronic or persistent infection that might worsen with immunosuppressive treatment.
- Patients known to be seropositive for HBV or have active HBV infection.
- Serious underlying medical conditions, which per the investigator's discretion could impair the ability of the patient to participate in the trial.
- Patients with uncontrolled hypertension.
- Known sensitivity or allergy to murine products.
- History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug.
- Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit.
- Treatment within a clinical trial within 4 weeks prior initiation of trial treatment.
- Refusal from patients with reproductive potential (males and females), of use of a medically acceptable method of contraception during the trial, i.e., a combination of two forms of effective contraception.
- Pregnancy or breast feeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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