Back to resultsA Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)
Primary Purpose
Myelodysplastic Syndrome (MDS)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lintuzumab
lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome (MDS) focused on measuring Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Combined Modality Therapy, Myelodysplastic Syndromes, Hematologic Diseases, Preleukemia
Eligibility Criteria
Inclusion Criteria:
- Disease confirmation of MDS.
- Between 5% and 30% blasts in the bone marrow.
- Received treatment for cytopenias within 2-months
- ECOG ≤ 2.
Exclusion Criteria:
- Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®).
- Received chemotherapy/radiotherapy within 4 weeks of study registration.
- Received prior bone marrow transplant.
- 5q- chromosomal deletion in malignant cells.
Sites / Locations
- University of Alabama at Birmingham
- Rocky Mountain Cancer Center
- Georgetown University
- Georgia Cancer Specialists
- St.Vincent's Comprehensive Cancer Center
- Memorial Sloan-Kettering Cancer Center
- Ohio State University
- Avera Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
lintuzumab and lenalidomide
Outcomes
Primary Outcome Measures
The incidence of adverse events and lab abnormalities
Secondary Outcome Measures
Antitumor activity
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00502112
Brief Title
A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)
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 Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome (MDS)
Keywords
Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Combined Modality Therapy, Myelodysplastic Syndromes, Hematologic Diseases, Preleukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
lintuzumab and lenalidomide
Intervention Type
Drug
Intervention Name(s)
lintuzumab
Other Intervention Name(s)
SGN-33
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle
Primary Outcome Measure Information:
Title
The incidence of adverse events and lab abnormalities
Time Frame
1 month after last dose
Secondary Outcome Measure Information:
Title
Antitumor activity
Time Frame
Every other 21-day cycle
Title
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)
Time Frame
1 month after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Disease confirmation of MDS.
Between 5% and 30% blasts in the bone marrow.
Received treatment for cytopenias within 2-months
ECOG ≤ 2.
Exclusion Criteria:
Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®).
Received chemotherapy/radiotherapy within 4 weeks of study registration.
Received prior bone marrow transplant.
5q- chromosomal deletion in malignant cells.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Sievers, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Georgia Cancer Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
St.Vincent's Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)
We'll reach out to this number within 24 hrs