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Phase I Study of Mitoxantrone and Etoposide Combined With Hydroxychloroquine, for Relapsed Acute Myelogenous Leukemia

NCT02631252 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-02-23

No results posted yet for this study

Summary

This is an open label phase I clinical trial of hydroxychloroquine (HCQ) ,when it is combined with the usual medications for acute myeloid leukemia, mitoxantrone and etoposide. The purpose of this study is to find the safest and most effective dose of hydroxychloroquine with these medications. The investigators will be testing to see if it can increase the effectiveness of mitoxantrone and etoposide.

Conditions

  • Leukemia, Acute Myelogenous

Interventions

DRUG

Hydroxychloroquine

Doses ranging from 600-1400mg daily in divided twice daily doses and administered orally.

DRUG

Mitoxantrone

Dose: 10mg/m2 IVPB in 50ml NS

DRUG

Etoposide

Dose: 100 mg/m2 administered intravenously in 500 ml of 0.9% sodium chloride

Sponsors & Collaborators

  • Alison Sehgal, MD, MS

    lead OTHER

Principal Investigators

  • Alison Sehgal, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-08-18
Primary Completion
2016-09-17
Completion
2017-10-02

Countries

  • United States

Study Locations

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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 NCT02631252 on ClinicalTrials.gov