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

July 13, 2007
October 7, 2011
March 2008
May 2010   (final data collection date for primary outcome measure)
The incidence of adverse events and lab abnormalities [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]
  • To define the safety profile of concurrent therapy with SGN-33 and lenalidomide in patients with MDS
  • To determine the maximum tolerated dose (MTD) of SGN-33 when administered in combination with lenalidomide.
Complete list of historical versions of study NCT00502112 on ClinicalTrials.gov Archive Site
  • 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 ]
  • To obtain preliminary antitumor activity of combination therapy in terms of decreased myeloblasts and hematologic improvement
  • To assess the pharmacokinetics (PK), immunogenicity, and cytokine profile of patients treated with SGN-33 and lenalidomide.
Not Provided
Not Provided
 
A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)
A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelodysplastic Syndrome (MDS)
  • 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
Experimental: 1
lintuzumab and lenalidomide
Interventions:
  • Drug: lintuzumab
  • Drug: lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00502112
SG033-0002
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Eric Sievers, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
October 2011

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