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

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: 5-Azacitidine; Drug: Gemtuzumab ozogamicin

• Registration Number: NCT00766116
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

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 Timeline

• Study Start: 2005-07
• Study First Submitted: 2008-10-02
• Study First Submitted QC: 2008-10-02
• Study First Posted: 2008-10-03
• Primary Completion: 2014-09-26
• Study Completion: 2014-09-26
• Results First Submitted: 2018-01-29
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-31
• Last Update Submitted: 2019-01-31
• Results First Posted: 2019-02-18
• Last Update Posted: 2019-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1 Dose Level 1	Gemtuzumab ozogamicin	5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m\^2 5-Aza 2 days then GO at 3 mg/m\^2
Phase 1 Dose Level 1	5-Azacitidine	5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m\^2 5-Aza 2 days then GO at 3 mg/m\^2
Phase 1 Dose Level 2	5-Azacitidine	5-Azacitidine, Gemtuzumab ozogamicin 75mg/m\^2 5-Aza for 4 days then GO at 6 mg/m\^2
Phase I Dose Level 3	5-Azacitidine	5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m\^2 5-Aza for 6 days then GO at 6 mg/m\^2
Phase 2 Dose Level 1	5-Azacitidine	5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m\^2 5-Aza for 6 days then GO at 6 mg/m\^2
Phase I Dose Level 3	Gemtuzumab ozogamicin	5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m\^2 5-Aza for 6 days then GO at 6 mg/m\^2
Phase 1 Dose Level 2	Gemtuzumab ozogamicin	5-Azacitidine, Gemtuzumab ozogamicin 75mg/m\^2 5-Aza for 4 days then GO at 6 mg/m\^2
Phase 2 Dose Level 1	Gemtuzumab ozogamicin	5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m\^2 5-Aza for 6 days then GO at 6 mg/m\^2

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Limiting Toxicities	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine	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

Trial Locations

Locations (3)

Northside Hospital/BMTGA; 🇺🇸 Atlanta, Georgia, United States

UCSD Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Stanford University; 🇺🇸 Stanford, California, United States