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

NCT00766116 | Completed Phase 1 Results DMC

• 1 other identifier: 090516
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

Phase 1 Dose Level 1

EXPERIMENTAL

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

Drug: 5-Azacitidine; Drug: Gemtuzumab ozogamicin

Phase 1 Dose Level 2

EXPERIMENTAL

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

Drug: 5-Azacitidine; Drug: Gemtuzumab ozogamicin

Phase I Dose Level 3

EXPERIMENTAL

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

Drug: 5-Azacitidine; Drug: Gemtuzumab ozogamicin

Phase 2 Dose Level 1

EXPERIMENTAL

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

Drug: 5-Azacitidine; Drug: Gemtuzumab ozogamicin

Interventions

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.

Also known as: Vidaz

Phase 1 Dose Level 1; Phase 1 Dose Level 2; Phase 2 Dose Level 1; Phase I Dose Level 3

Gemtuzumab ozogamicin DRUG

Mylotarg given 2 times over 2 weeks

Also known as: Mylotarg

Phase 1 Dose Level 1; Phase 1 Dose Level 2; Phase 2 Dose Level 1; Phase I Dose Level 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Celgene Corporation: collaborator
• Pfizer: collaborator

Study Sites (3)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Northside Hospital/BMTGA

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; Gemtuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Edward D. Ball, MD
• Organization: University of California, San Diego

tball@ucsd.edu

858-822-6600

Study Officials

• Edward D Ball, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 3, 2008
• Study Start: July 1, 2005
• Primary Completion: September 26, 2014
• Study Completion: September 26, 2014
• Last Updated: February 18, 2019
• Results First Posted: February 18, 2019

Record last verified: 2019-01

Locations

US (3)