A multicentre, phase III, open-label, randomised study in patients with advanced follicular lymphoma evaluating the benefit of maintenance therapy with Rituximab (MabThera®) after induction of response with chemotherapy plus Rituximab in comparison with no maintenance therapy - PRIMA
- Conditions
- Advanced follicular lymphoma
- Registration Number
- EUCTR2004-001756-36-GB
- Lead Sponsor
- GELA(RC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1202
a) Histologically confirmed follicular lymphoma grade 1, 2 or 3a, with a lymph node biopsy performed within 4 months before study entry and with material available for central review.
b) Patients not previously treated. Patients previously on watch and wait can enter the trial if a recent biopsy (obtained within the last 4 months) is available.
c) Bulky disease at study entry according to the GELF criteria:
nodal or extranodal mass >7cm in its greater diameter
or B symptoms
or elevated serum LDH or ß2microglobulin
or involvement of at least 3 nodal sites (each with a diameter> 3 cm)
or splenic enlargement
or compressive syndrome
or pleural/peritoneal effusion.
d) Age must be ³ 18 years.
e) Performance status £ 2 on the ECOG scale.
f) Adequate hematological function (unless those abnormalities are related to lymphoma extension) within 28 days prior to registration, including:
Hemoglobin = 8.0 g/dl (5.0 mmol/L)
Absolute neutrophil count (ANC) = 1.5 109/L
Platelet count = 100 109/L
g) Women are not breast feeding, are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
h) Having previously signed a written informed consent.
Inclusion criteria at Randomisation
a) All lesions reported in the on-study form have been re-evaluated.
b) Patient must have reached a PR, CRu or CR.
c) Patient should have received all full doses of induction treatment, excepted planned modifications.
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
a) Transformation to high-grade lymphoma (secondary to low-grade” FL).
b) Grade 3b follicular lymphoma.
c) Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis).
d) Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to £ 20 mg/day prednisone.
e) Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer.
f) Major surgery (excluding lymph node biopsy) within 28 days prior to registration.
g) Poor renal function: Serum creatinine > 2.0 mg/dl (197 µmol/L),
h) Poor hepatic function: Total bilirubin > 2.0 mg/dl (34 µmol/L), AST (SGOT) > 3 x the upper limit of normal unless these abnormalities are related to lymphoma.
i) Known HIV infection or active HBV or HCV infection = 4 weeks at registration.
j) Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). Judgment is up to the investigator.
k) Life expectancy < 6 months.
l) Known sensitivity or allergy to murine products.
m) Treatment within a clinical trial within 30 days prior to trial entry.
n) Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent.
Exclusion criteria at Randomisation
a) Serious underlying medical conditions which could impair the ability of the patient to participate.
b) Patient with delayed chemotherapy courses for more than 2 weeks
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