Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
5-Azacitidine
Gemtuzumab ozogamicin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML
Eligibility Criteria
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
Sites / Locations
- UCSD Moores Cancer Center
- Stanford University
- Northside Hospital/BMTGA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Phase 1 Dose Level 1
Phase 1 Dose Level 2
Phase I Dose Level 3
Phase 2 Dose Level 1
Arm Description
5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2
5-Azacitidine, Gemtuzumab ozogamicin 75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2
5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2
5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2
Outcomes
Primary Outcome Measures
Number of Participants With Dose Limiting Toxicities
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
Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine
Full Information
NCT ID
NCT00766116
First Posted
October 2, 2008
Last Updated
January 31, 2019
Sponsor
University of California, San Diego
Collaborators
Celgene Corporation, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00766116
Brief Title
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
Official Title
A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2005 (Actual)
Primary Completion Date
September 26, 2014 (Actual)
Study Completion Date
September 26, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Celgene Corporation, Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1 Dose Level 1
Arm Type
Experimental
Arm Description
5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2
Arm Title
Phase 1 Dose Level 2
Arm Type
Experimental
Arm Description
5-Azacitidine, Gemtuzumab ozogamicin
75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2
Arm Title
Phase I Dose Level 3
Arm Type
Experimental
Arm Description
5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2
Arm Title
Phase 2 Dose Level 1
Arm Type
Experimental
Arm Description
5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2
Intervention Type
Drug
Intervention Name(s)
5-Azacitidine
Other Intervention Name(s)
Vidaz
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gemtuzumab ozogamicin
Other Intervention Name(s)
Mylotarg
Intervention Description
Mylotarg given 2 times over 2 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Dose Limiting Toxicities
Description
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.
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward D Ball, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Northside Hospital/BMTGA
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
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