Selinexor (KPT-330) Plus FLAG-Ida for the Treatment of Relapsing/Refractory AML

Sponsor
PETHEMA Foundation
Study ID
NCT03661515
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    According to escalation level: * Level -1: Selinexor 40 mg/day, once weekly * Level 1: Selinexor 60 mg/day, once weekly * Level 2: Selinexor 80 mg/day, once weekly * Level 3: Selinexor 100 mg/day, once weekly
  • fludarabine — DRUG
    fludarabine 30 mg/m2/day intravenously on days 1 to 4
  • idarubicin — DRUG
    idarubicin 10 mg/m2/day intravenously on days 1 to 3
  • cytarabine — DRUG
    cytarabine 2 g/m2/day intravenously on days 1 to 4
  • G-CSF — DRUG
    G-CSF 300 mcg/m2/day subcutaneously from days -1 to 5

Study Details

This protocol corresponds to a multicenter, open-label, non-randomized, phase I study designed to determine the safety of the combination of selinexor with chemotherapy in young patients with relapsed or refractory AML. The clinical trial is divided into pre-treatment, treatment (induction and consolidation cycles) and follow-up periods and consists of a phase I design in which es-calating doses of selinexor will be given to 3 groups, each with 3-6 patients until achieving the maximum tolerated dose (MTD).

Key Dates

Start date
Jul 17, 2018
Status verified
May 2020
Primary completion
Jul 15, 2019
Completion
Oct 15, 2019

Study Design

Enrollment
16 participants (actual)
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Fludarabine-Idarubicine-Cytarabine- Selinexor
    fludarabine 30 mg/m2/day intravenously on days 1 to 4, idarubicin 10 mg/m2/day intravenously on days 1 to 3, cytarabine 2 g/m2/day intravenously on days 1 to 4, G-CSF 300 mcg/m2/day subcutaneously from days -1 to 5. This schedule will be combined with oral selinexor (KPT-330) for three weeks at days and dose according to escalation level: * Level -1: Selinexor 40 mg/day, once weekly * Level 1: Selinexor 60 mg/day, once weekly * Level 2: Selinexor 80 mg/day, once weekly * Level 3: Selinexor 100 mg/day, once weekly

Primary Outcome Measure

Maximum tolerated dose (MTD) of selinexor in combination with FLAG-Ida regimen [ Time Frame: At the end of Cycle 1 (each cycle is 56 days) ]

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