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

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. Identifier: NCT00502112
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : October 12, 2011
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Myelodysplastic Syndrome (MDS) Drug: lintuzumab Drug: lenalidomide Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
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)
Study Start Date : March 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

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

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.

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 identifier (NCT number): NCT00502112

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.
Study Director: Eric Sievers, MD Seattle Genetics, Inc.

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

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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
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