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NCT01889797 · ClinicalTrials.gov registry record · Phase 2
Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
A Phase 2 study, sponsored by PrECOG.
- Terminated
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT01889797 is a Phase 2 study that was terminated before completion, run by PrECOG. The registered enrollment target is 32 participants.
The verdict
NCT01889797, a Phase 2 study, was terminated before completion, sponsored by PrECOG.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL Arm A: Rituximab
- BIOLOGICAL Arm B: GA101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01889797
The ClinicalTrials.gov registry entry for NCT01889797 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PrECOG, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Arm A: Rituximab is the first listed.
NCT01889797 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01889797 about?
NCT01889797 is a clinical study titled "Phase II Randomized Trial Comparing GA101 and Rituximab in Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma". 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...
What is the current status of trial NCT01889797?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2013-12. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01889797?
The interventions under investigation include: Arm A: Rituximab (BIOLOGICAL), Arm B: GA101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01889797?
This trial is sponsored by PrECOG, which has 17 total clinical trials registered on ClinicalTrials.gov.
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