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Completed

NCT Number: NCT00766116

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UCSD Moores Cancer Center, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-Azacitidine

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.

Other names: Vidaz

Gemtuzumab Ozogamicin

Drug

Mylotarg given 2 times over 2 weeks

Other names: Mylotarg

Primary outcomes

  1. Number of Participants With Dose Limiting Toxicities

    Time frame: up to 28 days

    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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Celgene Corporation
  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Oct 3, 2008
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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