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A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Follicular Lymphoma

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Trial Information

A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall response rate in patients with FL

Outcome Description:

Overall response rate

Outcome Time Frame:

24 weeks

Safety Issue:

No

Authority:

Brazil: Ministry of Health

Study ID:

GP13-301

NCT ID:

NCT01419665

Start Date:

December 2011

Completion Date:

March 2014

Related Keywords:

  • Follicular Lymphoma
  • Follicular Lymphoma
  • Biosimilar
  • GP13-301
  • rituximab
  • Antibodies
  • CD20
  • Lymphoma
  • Lymphoma, Follicular

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