International Trial of Selumetinib in Combination With Dexamethasone for the Treatment of Acute Lymphoblastic Leukaemia

Phase 1/2 Terminated 12 enrolled University of Birmingham AstraZeneca · collab Cancer Research UK · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This trial is to investigate the combination of selumetinib and dexamethasone in the treatment of acute lymphoblastic leukaemia (ALL) in both adults and children. Phase I is to find the most suitable dose of selumetinib to safely give with dexamethasone. Phase II will use this dose to find out how well the combination works.

Timeline

Start: 2018-05-18
Primary completion: 2023-05-03
Completion: 2023-05-03

Publications

Background Menne T, Slade D, Savage J, Johnson S, Irving J, Kearns P, Plummer R, Shenton G, Veal GJ, Vormoor B, Vormoor J, Billingham L. Selumetinib in combination with dexamethasone for the treatment of relapsed/refractory RAS-pathway mutated paediatric and adult acute lymphoblastic leukaemia (SeluDex): study protocol for an international, parallel-group, dose-finding with expansion phase I/II trial. BMJ Open. 2022 Mar 4;12(3):e059872. doi: 10.1136/bmjopen-2021-059872.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selumetinib	Small molecule	—	Oral
Background	Dexamethasone	Small molecule	6 mg/m2	Oral

International Trial of Selumetinib in Combination With Dexamethasone for the Treatment of Acute Lymphoblastic Leukaemia

Summary

Timeline

Publications

Drugs

Indications