Trial for Relapsed or Refractory AML Patients Combining Cytarabine and Mitoxantrone With Venetoclax (RELAX)

Summary

This is an open-label Phase I dose-escalation study of oral venetoclax in combination with increasing cytarabine doses plus mitoxantrone to define the safety profile and MTD of cytarabine in subjects with a histologically or cytologically confirmed acute myeloid leukemia who are refractory or suffered a relapse. This study will be conducted at multiple centers in Germany.

Timeline

Start

2020-04-06

Primary completion

2023-10-11

Completion

2025-08

Publications

• Ruhnke L, Schliemann C, Mikesch JH, Stelljes M, Fransecky L, Steffen B, Kaufmann M, Burchert A, Rank A, Hanoun M, Hollein A, Kraus S, Schafer-Eckart K, Hanel M, Haake A, Fiebig F, Kramer M, Zukunft S, Kunadt D, Middeke JM, Sockel K, Schetelig J, Platzbecker U, von Bonin M, Rohnert MA, Oelschlagel U, Wagenfuhr L, Thiede C, Herold S, Poitz D, Stolzel F, Baldus CD, Serve H, Wermke M, Bornhauser M, Rollig C. Venetoclax plus high-dose cytarabine and mitoxantrone as salvage treatment for relapsed or refractory acute myeloid leukaemia (RELAX): a multicentre, single-arm, phase 1/2 trial. Lancet Haematol. 2026 Mar;13(3):e157-e168. doi: 10.1016/S2352-3026(25)00358-8.

Drugs

Indications