Status and phase
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About
Objectives
Study Design This is an international open-label, multicentre, randomized study with two treatment phases. In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation. After the maintenance period patients will be included in the follow up phase for 3 years.
Full description
Study medication
Enrollment
Sex
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Volunteers
Inclusion criteria
Histologically confirmed follicular lymphoma grade 1, 2 or 3a.
Patients previously untreated.
Patients with at least one of the following symptoms requiring initiation of treatment:
Age must be > 18 years.
Performance status < 2 on the ECOG scale (see appendix E).
Adequate hematological function within 28 days prior to registration (unless those abnormalities are related to lymphoma extension), this includes:
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.
Having previously signed a written informed consent form.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,217 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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