Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Conditions

• Indolent Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Arm A: Rituximab — BIOLOGICAL
  Rituximab 375 mg/m² IV x 4 weekly doses.
• Arm B: GA101 — BIOLOGICAL
  GA101 1,000 mg (flat dose) IV x 4 weekly doses.

Study Details

Patients with previously untreated low tumor burden indolent Non-Hodgkin's Lymphoma (NHL) will receive either rituximab or GA101 weekly for 4 weeks followed by re-staging to determine response. Rituximab, an anti-CD20 chimeric antibody, was approved by the United States Food and Drug Administration in 1998 for the treatment of patients with relapsed low-grade B-cell lymphomas. Clinically, four weekly doses of rituximab have proven to be well tolerated and effective in previously untreated as well as relapsed patients with low-grade lymphoma. GA101 is an anti-CD20 humanized and glyco-engineered monoclonal antibody. GA101 has been shown to have increased antibody-dependent cellular cytotoxicity (ADCC) and direct cell-death induction compared to Rituximab. It is possible that GA101 may have greater efficacy than rituximab. PrE0401 Sub-Study Evaluation of Corrected QT (QTc) Interval and Pharmacokinetic Parameters in Patients Participating in GA101 (Obinutuzumab) Approximately twenty-five patients randomized to GA101 may participate in the sub-study. Electrocardiograms and blood samples will be obtained.

Key Dates

Start date

Dec 31, 2013

Status verified

Mar 2017

Primary completion

Apr 30, 2016

Completion

Aug 31, 2016

Study Design

Enrollment

32 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A: Rituximab
  Rituximab 375 mg/m² IV weekly for 4 weeks.
• Experimental: Arm B: GA101
  GA101 1,000 mg IV weekly for 4 weeks.

Primary Outcome Measure

Complete Response (CR) Rate [ Time Frame: Re-staging (week 12, 13 or 14) and during follow-up if physician feels patient is subsequently in CR for up to 4 years ]

Locations (28)

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