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

NCT03661515 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-05-20

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Selinexor

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

DRUG

fludarabine

fludarabine 30 mg/m2/day intravenously on days 1 to 4

DRUG

idarubicin

idarubicin 10 mg/m2/day intravenously on days 1 to 3

DRUG

cytarabine

cytarabine 2 g/m2/day intravenously on days 1 to 4

DRUG

G-CSF

G-CSF 300 mcg/m2/day subcutaneously from days -1 to 5

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2019-07-15
Completion
2019-10-15

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

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 NCT03661515 on ClinicalTrials.gov