WHO ICTRP trial
This study is to evaluate the safety and pharmacokinetics of Epcoritamab in…
EUCTR2021-004555-16-ES · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-004555-16-ES |
|---|---|
| Public title | This study is to evaluate the safety and pharmacokinetics of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms |
| Scientific title | A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms - Mature B-cell Neoplasms: Phase 1 Study of Epcoritamab in Pediatric Patients |
| Primary sponsor | AbbVie Deutschland GmbH & Co. KG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United States;Czechia;Spain;Turkey;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Korea, Republic of |
| Conditions | Relapsed/refractory Burkitt's or Burkitt-like lymphoma/leukemia, Diffuse large B-cell lymphoma , or other aggressive mature (CD20+) B-cell lymphomas MedDRA version: 20.0 Level: HLT Classification code 10006596 Term: Burkitt's lymphomas… |
| Interventions | Product Name: Epcoritamab Product Code: ABBV-GMAB-3013 Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Epcoritamab CAS Number: 2134641-34-0 Current Sponsor code: ABBV-GMAB-3013 Concentration unit: mg/ml… |
| Registration date | Dec 16, 2021 |
| Target size | 15 |
| Secondary IDs | M20-429 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: