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OpenTrials
Completed

NCT Number: NCT00528333

A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML

The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.

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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

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southern Cancer Center, Mobile, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder.
  • After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML.
  • At least 20% blasts in blood or marrow.
  • Must have a minimum of 50% leukemic blasts that express CD33.
  • ECOG performance status score of 0 to 2.
  • WBC less than 30,000/µL

Exclusion criteria

  • No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.
  • No other active systemic malignancies treated with chemotherapy within the last 12 months.
  • Must not have received previous chemotherapy (except hydroxyurea) for AML.
  • Must not have significantly abnormal kidney or liver disease.
  • Must not have known human immunodeficiency virus (HIV).

Treatment and study plan

Lintuzumab (SGN-33)

Drug

600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles.

Other names: SGN-33

Low dose cytarabine

Drug

20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.

Other names: Ara-C, Cytosar

Placebo

Drug

IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles

Primary outcomes

  1. Overall survival

    Time frame: 12 months

Secondary outcomes

  1. Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics

    Time frame: 13 months

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study title

A Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older With Previously Untreated AML

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 12, 2007
Registry last updated
Jan 7, 2015

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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