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Clinical Trials/EUCTR2012-003230-17-NL
EUCTR2012-003230-17-NLActive, not recruitingPhase 1

A RANDOMIZED, OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE PATIENT PREFERENCE WITH SUBCUTANEOUS ADMINISTRATION OF RITUXIMAB VERSUS INTRAVENOUS RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CD20+ DIFFUSE LARGE B-CELL LYMPHOMA OR CD20+ FOLLICULAR NON-HODGKIN’S LYMPHOMA GRADES 1, 2 OR 3A

F. Hoffmann-La Roche Ltd.0 sites700 target enrollmentStarted: November 2, 2012Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
700
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Age = 18 and = 80 years at time of randomization
  • •2. Histologically confirmed, previously untreated CD20+ DLBCL or CD20+ follicular NHL Grade 1, 2 or 3a, according to the WHO classification system
  • •3. An IPI score of 1-4 or IPI score of 0 with bulky disease, defined as one lesion = 7.5 cm, or FLIPI (low, low-intermediate, high-intermediate, high)
  • •4. At least one bi-dimensionally measurable lesion defined as = 1.5 cm in its largest dimension on CT scan
  • •5. Eastern Cooperative Oncology Group (ECOG) performance status = 3.
  • •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 700
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

  • •1. Transformed lymphoma or FL IIIB
  • •2. Primary CNS lymphoma, blastic variant of mantle-cell lymphoma, histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL or primary DLBCL of the testis
  • •3. History of other malignancy that could affect compliance with the protocol or interpretation of results. This includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for = 5 years prior to enrolment. Note: Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible for the study.
  • •4.Prior therapy for DLBCL or follicular NHL, with the exception of nodal biopsy or local irradiation
  • •5.Prior treatment with cytotoxic drugs (with the exclusion of methotrexate for CNS prophylaxis in DLBCL) or rituximab for another condition (e.g., rheumatoid arthritis) or prior use of an anti-CD20 antibody
  • •6.Prior use of any monoclonal antibody within 3 months prior to randomization

Investigators

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