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

Stopped early · Phase 2

Conditions studied: Indolent Non-Hodgkin's Lymphoma

In brief

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 facts

Study ID

NCT01889797

Run by

PrECOG, LLC.

People needed

32

Starts

2013-12-01

Expected to finish

2016-08-01

Last updated by the study team

2017-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Registration: Patients having both diffuse and follicular architectural elements will be considered eligible if the histology is predominantly follicular (≥ 50% of the cross-sectional area), and there is no evidence of transformation to a large cell histology.
• Biopsy-proven diagnosis of Grade 1 or 2 follicular non-Hodgkin's lymphoma with no evidence of transformation to large cell histology.
• Meet criteria for Low Tumor Burden:
• No nodal or extra nodal mass ≥ 7 centimeter (cm)
• <3 nodal masses >3 cm in diameter
• No systemic symptoms or B symptoms
• No splenomegaly >16 cm by CT scan
• No risk of compression of a vital organ.
• No leukemic phase with >5000/mm³ circulating lymphocytes.
• No cytopenias defined as:
• Platelets <100,000/mm³
• Hemoglobin (Hgb) <10 g/dL
• Absolute Neutrophil Count (ANC) <1500/mm³
• Must have Stage III or Stage IV disease.
• Baseline measurements/evaluations obtained within 6 weeks of registration. Patient must have at least one objective measurable disease parameter.
• Age ≥ 18 years.
• Eastern Oncology Cooperative Group Performance Status 0-1.
• Must not have received investigational agents within 30 days of registration.
• Signed Institutional Review Board (IRB)-approved informed consent.
• Willing to provide blood samples for research purposes.
• Women must not be pregnant or breastfeeding.
• Women of childbearing potential and sexually active males must use an accepted and effective method of contraception.
• No prior chemotherapy, radiotherapy or immunotherapy for lymphoma.
• No prior treatment with cytotoxic drugs or rituximab for a previous cancer or another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody.
• No prior use of any monoclonal antibody within 3 months of randomization.

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Marin Cancer Care — Greenbrae, California, United States
• St. Joseph's/Candler Health System — Savannah, Georgia, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Siouxland Hematology Oncology Associates — Sioux City, Iowa, United States
• Ochsner Cancer Institute — New Orleans, Louisiana, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• St. Joseph Mercy Health System — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Metro MN CCOP — Saint Louis Park, Minnesota, United States
• Missouri Valley Cancer Consortium — Omaha, Nebraska, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Aultman Hospital — Canton, Ohio, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Toledo Community Oncology Program — Toledo, Ohio, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Reading Hospital — West Reading, Pennsylvania, United States
• Susquehanna Health Cancer Center — Williamsport, Pennsylvania, United States
• University of Virginia — Charlottesburg, Virginia, United States
• Charleston Area Medical Center (CAMC) — Charleston, West Virginia, United States
• Gundersen Health System — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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