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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766116
• Other study ID #: 090516
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2005
• Est. completion date: September 26, 2014

Study information

• Verified date: January 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 26, 2014
• Est. primary completion date: September 26, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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.
• Gemtuzumab ozogamicin
Mylotarg given 2 times over 2 weeks

Locations

Country	Name	City	State
United States	Northside Hospital/BMTGA	Atlanta	Georgia
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Celgene Corporation, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 28 days
Secondary	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