Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)

January 31, 2019 updated by: Edward Ball, University of California, San Diego

A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML

This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two times over two weeks

In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.

A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UCSD Moores Cancer Center
      • Stanford, California, United States, 94305
        • Stanford University
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital/BMTGA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Relapsed AML
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy > 3 months
  • ≥ 18 years old
  • Previously untreated for current AML relapse
  • Adequate organ function
  • Written informed consent

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days
  • Currently receiving another investigational drug
  • Currently receiving other anti-cancer agents
  • Uncontrolled infection
  • HIV positive
  • Received previous therapy with either Mylotarg or 5-azacitidine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 Dose Level 1

5-Azacitidine, Gemtuzumab ozogamicin

75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2
Drug: 5-Azacitidine
Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit.
Other Names:
  • Vidaz
Drug: Gemtuzumab ozogamicin
Mylotarg given 2 times over 2 weeks
Other Names:
  • Mylotarg
Experimental: Phase 1 Dose Level 2

5-Azacitidine, Gemtuzumab ozogamicin

75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2
Drug: 5-Azacitidine
Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit.
Other Names:
  • Vidaz
Drug: Gemtuzumab ozogamicin
Mylotarg given 2 times over 2 weeks
Other Names:
  • Mylotarg
Experimental: Phase I Dose Level 3

5-Azacitidine, Gemtuzumab ozogamicin

75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2
Drug: 5-Azacitidine
Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit.
Other Names:
  • Vidaz
Drug: Gemtuzumab ozogamicin
Mylotarg given 2 times over 2 weeks
Other Names:
  • Mylotarg
Experimental: Phase 2 Dose Level 1

5-Azacitidine, Gemtuzumab ozogamicin

75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2
Drug: 5-Azacitidine
Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit.
Other Names:
  • Vidaz
Drug: Gemtuzumab ozogamicin
Mylotarg given 2 times over 2 weeks
Other Names:
  • Mylotarg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Dose Limiting Toxicities
Time Frame: up to 28 days
MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days.
up to 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine
Time Frame: Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years
Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Pfizer
Celgene Corporation

Investigators

  • Principal Investigator: Edward D Ball, MD, UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2005

Primary Completion (Actual)

September 26, 2014

Study Completion (Actual)

September 26, 2014

Study Registration Dates

First Submitted

October 2, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (Estimate)

October 3, 2008

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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