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Pracinostat and Gemtuzumab Ozogamicin (PraGO) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT03848754 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-06-30

No results posted yet for this study

Summary

This is a prospective, single-center phase 1 clinical study aimed at determining the maximum-tolerated dose and safety of the combination of gemtuzumab ozogamicin (GO) and pracinostat (P) in patients with relapsed/refractory acute myeloid leukemia.

Conditions

  • Relapsed Adult AML

Interventions

DRUG

Gemtuzumab Ozogamicin 3 mg/m^2

GO 3 mg/m\^2 on Day 1, 4, and 7 Maintenance: 2mg/m2 intravenous administration on day 1, in a 28-day cycle.

DRUG

Gemtuzumab Ozogamicin 2 mg/m^2

GO 2 mg/m\^2 on Day 1 of a 28-day cycle.

DRUG

Pracinostat - 45 mg

Induction: 45mg administered orally 3 days a week with 48 hours between dosing (e.g., Monday, Wednesday, and Friday) for three consecutive weeks, followed by 1 week of rest, in 28-day cycles.

DRUG

Pracinostat - 60 mg

Escalation: 60 mg administered orally three days a week with 48 hours between dosing (e.g., Monday, Wednesday, and Friday) for three consecutive weeks, followed by one week of rest, in 28-day cycles.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Sameem Abedin, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-24
Primary Completion
2021-05-05
Completion
2021-05-05
FDA Drug
Yes

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 NCT03848754 on ClinicalTrials.gov