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

NCT ID: NCT00766116

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2014-09-26

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 Dose Level 1

5-Azacitidine, Gemtuzumab ozogamicin

75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2

Group Type: EXPERIMENTAL

5-Azacitidine

Intervention Type: DRUG

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

Intervention Type: DRUG

Mylotarg given 2 times over 2 weeks

Phase 1 Dose Level 2

5-Azacitidine, Gemtuzumab ozogamicin

75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2

Group Type: EXPERIMENTAL

5-Azacitidine

Intervention Type: DRUG

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

Intervention Type: DRUG

Mylotarg given 2 times over 2 weeks

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

Group Type: EXPERIMENTAL

5-Azacitidine

Intervention Type: DRUG

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

Intervention Type: DRUG

Mylotarg given 2 times over 2 weeks

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

Group Type: EXPERIMENTAL

5-Azacitidine

Intervention Type: DRUG

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

Intervention Type: DRUG

Mylotarg given 2 times over 2 weeks

Interventions

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.

Intervention Type: DRUG

Gemtuzumab ozogamicin

Mylotarg given 2 times over 2 weeks

Intervention Type: DRUG

Other Intervention Names

Vidaz; Mylotarg

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Edward Ball

Professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward D Ball, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

UCSD Moores Cancer Center

La Jolla, California, United States

Stanford University

Stanford, California, United States

Northside Hospital/BMTGA

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

090516

Identifier Type: -

Identifier Source: org_study_id