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

University of California, San Diego50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

5-AzacitidineDRUG

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 ozogamicinDRUG

Mylotarg given 2 times over 2 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (3)

UCSD Moores Cancer Center

La Jolla, California, United States

Stanford University

Stanford, California, United States

Northside Hospital/BMTGA

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: up to 28 days

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.