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

NCT03705507 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-11

No results posted yet for this study

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.

Conditions

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia, Adult
  • Acute Lymphoblastic Leukemia, Pediatric
  • Acute Lymphoblastic Leukemia, in Relapse
  • Acute Lymphoblastic Leukemia Recurrent

Interventions

DRUG

Selumetinib

Selumetinib is a small molecule inhibitor of the MEK protein

DRUG

Dexamethasone

Steroid used for the treatment and management of a number of conditions including cancers and leukaemias.

Sponsors & Collaborators

Principal Investigators

  • Tobias Menne · The Newcastle Hospitals NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Denmark
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705507 on ClinicalTrials.gov