GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

Sandoz

Status and phase: Completed; Phase 3

Conditions: Follicular Lymphoma

Treatments: Biological: rituximab; Biological: GP2013

Study type: Interventional

Funder types: Industry

Identifiers

NCT01419665

GP13-301

2010-019522-13 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.

Enrollment: 629 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with previously untreated advanced stage, CD20-positive FL
• Patient with ECOG performance status 0, 1 or 2.

Exclusion criteria

• Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a
• Patient who has previously received any prior therapy for lymphoma
• Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal).
• Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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629 participants in 2 patient groups

GP2013

Experimental group

Description:

Type: Biological/Vaccine

Treatment:

Biological: GP2013

rituximab

Active Comparator group

Description:

Type: Biological/Vaccine

Treatment:

Biological: rituximab