Phase-I/II trial for relapsed or refractory AML patients combining cytarabine and mitoxantrone with venetoclax (TUD-RELAX1-070)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514018-12-00

Acronym

TUD-RELAX1-070

Enrollment

Registered

2024-10-18

Start date

2020-04-06

Completion date

2025-09-24

Last updated

2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

female and male adult patients with acute myeloid leukemia (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 intensive salvage treatment

Brief summary

Phase I (Escalation part): Maximum tolerated dose of cytarabine in combination with venetoclax plus mitoxantrone in the framework of a 3+3 design, Phase II (Expansion part): CR/CRi rate

Interventions

DRUGVenetoclax

DRUGMITOXANTRONE

DRUGCYTARABINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase I (Escalation part): Maximum tolerated dose of cytarabine in combination with venetoclax plus mitoxantrone in the framework of a 3+3 design, Phase II (Expansion part): CR/CRi rate	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026