Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-005585
NCT ID: NCT01889797
Sponsor Protocol Number: PrE0401
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
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.
- No history of severe allergic/anaphylactic reactions to humanized/murine monoclonal antibodies or known sensitivity/allergy to murine products.
- No history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least 2 years and did not require treatment with cytotoxic drugs or rituximab.
- No major surgery within 4 weeks prior to randomization, other than for diagnosis.
- Must be Human Immunodeficiency Virus (HIV) negative.
- Have adequate organ function without growth factor and/or transfusion support within ≤ 2 weeks prior to registration:
- ANC ≥ 1500/mm³
- Hgb ≥ 10 g/dL
- Platelets ≥ 100,000/mm³
- Serum Creatinine ≤ 2x Upper Limit Normal (ULN)
- Total Bilirubin ≤ 2x ULN
- AST (aspartate aminotransferase)/ALT (alanine aminotransferase) ≤ 5x ULN
- PTT (Partial Thromboplastin Time) or aPTT (activated Partial Thromboplastin Time) >1.5x the ULN in the absence of a lupus anticoagulant
- INR (International Normalized Ratio) >1.5x the ULN in the absence of therapeutic anticoagulation
- No active, uncontrolled infections (afebrile for ≥ 48 hours off antibiotics).
- Must not receive immunization with attenuated live vaccines within 28 days prior to registration or during the study period.
- Must be tested for hepatitis B surface antigen (HBsAg) and total hepatitis B core antibody (anti-HBc) within 2 weeks of registration. Patients who are chronic carriers of HBsAg and anti-HBc are excluded.
- Must be tested for hepatitis C antibody within 2 week of registration. If this test is positive, patients are excluded unless a hepatitis C virus ribonucleic acid (HCV RNA) is negative.
- No evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (i.e., severe arrhythmia, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Stephen Ansell, M.D., Ph.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office