NCT00195000

Brief Summary

The purpose of this study is to find out how safe and effective the combination of Mylotarg in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and advanced Myelodysplastic Syndrome over the age of 60 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

June 17, 2013

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Keywords

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and efficacy of gemtuzumab ozogamicin (Mylotarg) in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years.

    From entry until 30 days post treatment.

Interventions

MylotargDRUG

6 mg/m2 on day 1

Also known as: Gemtuzumab Ozogamicin
CytarabineDRUG

100 mg/m2 given as continuous infusion daily for 7 days.

Also known as: Ara-C

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic diagnosis of AML or advanced MDS
  • No prior cytotoxic treatment for AML. (patients may have been treated with prior biologic therapy) Patients with MDS or AML that has evolved from MDS, could have received prior low-dose cytotoxic therapy (i.e. azacytidine or low-dose ara-C).

You may not qualify if:

  • Uncontrolled or severe cardiovascular disease or pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medcial College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

GemtuzumabCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Eric Feldman, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

May 1, 2003

Primary Completion

May 1, 2006

Study Completion

February 1, 2008

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)