WHO ICTRP trial
Addition of venetoclax to standard chemotherapy with cytarabine and mitoxantrone…
EUCTR2018-003025-28-DE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2018-003025-28-DE |
|---|---|
| Public title | Addition of venetoclax to standard chemotherapy with cytarabine and mitoxantrone in patients with relapsed or refractory acute myeloid leukemia (AML) |
| Scientific title | Phase-I/II trial for relapsed or refractory AML patients combining cytarabine and mitoxantrone with venetoclax - RELAX |
| Primary sponsor | Technische Universität Dresden |
| 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): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Germany |
| Conditions | Patients 18-75 years with acute myeloid leukaemia (AML) at first or second relapse after intensive chemotherapy including allogeneic stem cell transplantation or primary refractory to standard induction chemotherapy who are eligible for… |
| Interventions | Product Name: venetoclax Product Code: ABT-199 Pharmaceutical Form: Coated tablet INN or Proposed INN: VENETOCLAX CAS Number: 1257044-40-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name… |
| Registration date | Jan 29, 2019 |
| Target size | 54 |
| Secondary IDs | TUD-RELAX1-070 |
| 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: