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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00502112
First received: July 13, 2007
Last updated: October 7, 2011
Last verified: October 2011
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antitumor activity [ Time Frame: Every other 21-day cycle ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA) [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
St.Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
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

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00502112     History of Changes
Other Study ID Numbers: SG033-0002
Study First Received: July 13, 2007
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014