We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502112
First Posted: July 17, 2007
Last Update Posted: October 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
  Purpose
This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy.

Condition Intervention Phase
Myelodysplastic Syndrome (MDS) Drug: lintuzumab Drug: lenalidomide Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • The incidence of adverse events and lab abnormalities [ Time Frame: 1 month after last dose ]

Secondary Outcome Measures:
  • Antitumor activity [ Time Frame: Every other 21-day cycle ]
  • Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA) [ Time Frame: 1 month after last dose ]

Enrollment: 13
Study Start Date: March 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
lintuzumab and lenalidomide
Drug: lintuzumab
4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle
Other Name: SGN-33
Drug: lenalidomide
10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle
Other Name: Revlimid

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Disease confirmation of MDS.
  2. Between 5% and 30% blasts in the bone marrow.
  3. Received treatment for cytopenias within 2-months
  4. ECOG ≤ 2.

Exclusion Criteria:

  1. Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®).
  2. Received chemotherapy/radiotherapy within 4 weeks of study registration.
  3. Received prior bone marrow transplant.
  4. 5q- chromosomal deletion in malignant cells.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502112


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30342
United States, New York
St.Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Eric Sievers, MD Seattle Genetics, Inc.
  More Information

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00502112     History of Changes
Other Study ID Numbers: SG033-0002
First Submitted: July 13, 2007
First Posted: July 17, 2007
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Seattle Genetics, Inc.:
Lintuzumab
Antigens, CD33
Antibodies, Monoclonal
Combined Modality Therapy
Myelodysplastic Syndromes
Hematologic Diseases
Preleukemia

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Lenalidomide
Thalidomide
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents