WHO ICTRP trial
First line therapy of patients < 60 years suffering from advanced follicular…
EUCTR2016-000755-27-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2016-000755-27-DE |
|---|---|
| Public title | First line therapy of patients < 60 years suffering from advanced follicular lymphoma who are not in the state of health for the standard immunochemotherapy or for all patients = 60 years. It is a forward-looking comparison of two therapy schemes wherein the patients are assigned to the particular test group according to a special mathematical based principle. In arm 1 only GA 101 and in arm 2 GA 101 and Bendamustin is administered. After the initial therapy only GA 101 is given in both arms. |
| Scientific title | FIRST LINE THERAPY OF ADVANCED STAGE FOLLICULAR LYMPHOMA IN PATIENTS < 60 YEARS NOT ELIGIBLE FOR STANDARD IMMUNOCHEMOTHERAPY AND ALL PATIENTS = 60 YEARS Prospective randomized evaluation of single agent GA101 versus GA101 plus Bendamustine followed by GA101 - GABe2016 |
| Primary sponsor | Klinikum der Universität München |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Germany |
| Conditions | Evaluation of the efficacy and toxicity of GA 101 versus GA 101 plus Bendamustin, followed by GA 101 in medically non-fit patients < 60 years and in all patients = 60 years as first line therapy of advanced stage follicular lymphoma MedDRA… |
| Interventions | Trade Name: Gazyvaro® Product Name: Gazyvaro®, Obinutuzumab® Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: OBINUTUZUMAB CAS Number: 949142-50-1 Other descriptive name: OBINUTUZUMAB Concentration unit: mg… |
| Registration date | Jul 7, 2016 |
| Target size | 46 |
| Secondary IDs | GABe2016;NCT03492775 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: