A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

December 17, 2014 updated by: Seagen Inc.

A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Central Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46107
        • Indiana Oncology-Hematology Consultants
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Medical Center
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
      • New York, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Center Of The Carolinas
    • Texas
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients must have a diagnosis of MDS or AML.
  2. Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.

Exclusion Criteria:

  1. Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment.
  2. Patients with a prior allogeneic transplant.
  3. Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded.
  4. Patients receiving chemotherapy within the last four weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: lintuzumab
1.5 - 8 mg/kg IV (in the vein) on Days 1, 8, 15, 22 and 29 of Cycle 1; 1.5 - 8 mg/kg IV (in the vein) every other week for all subsequent cycles
Other Names:
  • SGN-33

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of adverse events and lab abnormalities.
Time Frame: 13 months
13 months
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).
Time Frame: 13 months
13 months
Antitumor activity.
Time Frame: 13 months
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Study Director: Eric Sievers, M.D., Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 25, 2006

First Submitted That Met QC Criteria

January 25, 2006

First Posted (Estimate)

January 27, 2006

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG033-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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