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

Primary Purpose

Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lintuzumab
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Hematologic Diseases, Myeloproliferative Disorders, Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must have a diagnosis of MDS or AML. Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months. Exclusion Criteria: Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment. Patients with a prior allogeneic transplant. Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded. Patients receiving chemotherapy within the last four weeks.

Sites / Locations

  • Rocky Mountain Cancer Center
  • Cancer Care Specialists of Central Illinois
  • Indiana Oncology-Hematology Consultants
  • University of Massachusetts Medical Center
  • St. Vincent's Comprehensive Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Weill Medical College of Cornell University
  • Cancer Center of the Carolinas
  • Scott & White Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

The incidence of adverse events and lab abnormalities.
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).
Antitumor activity.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2006
Last Updated
December 17, 2014
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00283114
Brief Title
A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Official Title
A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia
Keywords
Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Hematologic Diseases, Myeloproliferative Disorders, Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lintuzumab
Other Intervention Name(s)
SGN-33
Intervention Description
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
Primary Outcome Measure Information:
Title
The incidence of adverse events and lab abnormalities.
Time Frame
13 months
Title
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).
Time Frame
13 months
Title
Antitumor activity.
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have a diagnosis of MDS or AML. Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months. Exclusion Criteria: Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment. Patients with a prior allogeneic transplant. Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded. Patients receiving chemotherapy within the last four weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Sievers, M.D.
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Cancer Care Specialists of Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Indiana Oncology-Hematology Consultants
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
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
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cancer Center of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19557623
Citation
Raza A, Jurcic JG, Roboz GJ, Maris M, Stephenson JJ, Wood BL, Feldman EJ, Galili N, Grove LE, Drachman JG, Sievers EL. Complete remissions observed in acute myeloid leukemia following prolonged exposure to lintuzumab: a phase 1 trial. Leuk Lymphoma. 2009 Aug;50(8):1336-44. doi: 10.1080/10428190903050013.
Results Reference
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A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

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