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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00283114
First received: January 25, 2006
Last updated: June 6, 2013
Last verified: June 2013

January 25, 2006
June 6, 2013
November 2005
January 2010   (final data collection date for primary outcome measure)
  • The incidence of adverse events and lab abnormalities. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA). [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
  • Antitumor activity. [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • To study the safety profile of SGN-33 at higher doses and different administration schedule than previously tested.
  • To evaluate the pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA) of SGN-33 during weekly dosing.
  • To describe evidence for antitumor activity in a variety of CD33+ malignancies.
Complete list of historical versions of study NCT00283114 on ClinicalTrials.gov Archive Site
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A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Myeloproliferative Disorders
  • Chronic Myelomonocytic Leukemia
Drug: lintuzumab
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
Other Name: SGN-33
Experimental: 1
Intervention: Drug: lintuzumab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must have a diagnosis of MDS or AML.
  2. Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.

Exclusion Criteria:

  1. Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment.
  2. Patients with a prior allogeneic transplant.
  3. Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded.
  4. Patients receiving chemotherapy within the last four weeks.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00283114
SG033-0001
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Eric Sievers, M.D. Seattle Genetics, Inc.
Seattle Genetics, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP