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

University of California San Diego

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Gemtuzumab ozogamicin; Drug: 5-Azacitidine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00766116

090516

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Phase 1 Dose Level 1

Experimental group

Description:

5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m\^2 5-Aza 2 days then GO at 3 mg/m\^2

Treatment:

Drug: Gemtuzumab ozogamicin

Drug: 5-Azacitidine

Phase 1 Dose Level 2

Experimental group

Description:

5-Azacitidine, Gemtuzumab ozogamicin 75mg/m\^2 5-Aza for 4 days then GO at 6 mg/m\^2

Treatment:

Drug: Gemtuzumab ozogamicin

Drug: 5-Azacitidine

Phase I Dose Level 3

Experimental group

Description:

5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m\^2 5-Aza for 6 days then GO at 6 mg/m\^2

Treatment:

Drug: Gemtuzumab ozogamicin

Drug: 5-Azacitidine

Phase 2 Dose Level 1

Experimental group

Description:

5-Azacitidine, Gemtuzumab ozogamicin 75 mg/m\^2 5-Aza for 6 days then GO at 6 mg/m\^2

Treatment:

Drug: Gemtuzumab ozogamicin

Drug: 5-Azacitidine