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A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)


Phase 1
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome (MDS)

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Trial Information

A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The incidence of adverse events and lab abnormalities

Outcome Time Frame:

1 month after last dose

Safety Issue:

Yes

Principal Investigator

Eric Sievers, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SG033-0002

NCT ID:

NCT00502112

Start Date:

March 2008

Completion Date:

May 2010

Related Keywords:

  • Myelodysplastic Syndrome (MDS)
  • Lintuzumab
  • Antigens, CD33
  • Antibodies, Monoclonal
  • Combined Modality Therapy
  • Myelodysplastic Syndromes
  • Hematologic Diseases
  • Preleukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rocky Mountain Cancer CenterDenver, Colorado  80218
Georgia Cancer SpecialistsDecatur, Georgia  30033
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Georgetown UniversityWashington, District of Columbia  20007-2197
Ohio State UniversityColumbus, Ohio  43210
St.Vincent's Comprehensive Cancer CenterNew York, New York  10011