WHO ICTRP trial
A pivotal Phase II randomised, multi-centre, open-label study to evaluate the…
NL-OMON54269 · Overview of Medical Research in the Netherlands (NL-OMON) · Recruiting
Key facts
| Trial ID | NL-OMON54269 |
|---|---|
| Public title | A pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation |
| Scientific title | A pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL), who are not eligible for high-dose chemotherapy and autologous… |
| Primary sponsor | Miltenyi Biomedicine GmbH |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | 2 |
| Countries | Austria;Belgium;Czechia;France;Germany;Hungary;Italy;Lithuania;Netherlands;Spain;Sweden;United Kingdom |
| Conditions | Lymph node cancer; B-cell Non Hodgkin's lymphoma;10025320;Lymph node cancer; B-cell Non Hodgkin's lymphoma |
| Interventions | Single infusion of 2.5 × 106 CAR transduced autologous T cells per kg/body weight (BW) (with a maximum dose equivalent to 100 kg for participants with a body weight > 100 kg). The Investigational medicinal product (IMP) will be administered… |
| Registration date | Jul 31, 2023 |
| Target size | 30 |
| Secondary IDs | 2020-003908-14;NL76282.000.21 |
| Registry page | onderzoekmetmensen.nl |
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: