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

Sponsor
University of Birmingham
Study ID
NCT03705507
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selumetinib — DRUG
    Selumetinib is a small molecule inhibitor of the MEK protein
  • Dexamethasone — DRUG
    Steroid used for the treatment and management of a number of conditions including cancers and leukaemias.

Study Details

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.

Key Dates

Start date
May 18, 2018
Status verified
May 2023
Primary completion
May 3, 2023
Completion
May 3, 2023

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Selumetinib + Dexamethasone - Group A (18 years and above)
    Patients will receive the adult cohort specified dose of selumetinib by mouth, as a single dose on cycle 1 day 1, then twice daily continuously from cycle 1 day 4 onwards. Combined with pulsed doses of dexamethasone at 6mg/m2/day on days 2-4 and 8-11 then at 4mg/m2/day on days 15-18 and 22-25 divided into two doses (as per local practice) by mouth during cycle 1, then on days 1-4 at 4mg/m2/day at the start of cycle 2, then on days 1-5 at 6mg/m2/day during subsequent cycles.
  • Experimental: Selumetinib + Dexamethasone - Group P (under 18 years)
    Patients will receive the paediatric cohort specified dose of selumetinib by mouth, as a single dose on cycle 1 day 1, then twice daily continuously from cycle 1 day 4 onwards. Combined with pulsed doses of dexamethasone at 6mg/m2/day on days 2-4 and 8-11 then at 4mg/m2/day on days 15-18 and 22-25 divided into two doses (as per local practice) by mouth during cycle 1, then on days 1-4 at 4mg/m2/day at the start of cycle 2, then on days 1-5 at 6mg/m2/day during subsequent cycles.

Primary Outcome Measure

Phase I: The occurrence/non-occurrence of dose limiting toxicities (DLTs) in the trial defined assessment period [ Time Frame: During cycle 1 (each cycle is 28 days) ]

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