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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502112

Enrollment

Registered

2007-07-17

Start date

2008-03-31

Completion date

2010-05-31

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome (MDS)

Keywords

Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Combined Modality Therapy, Myelodysplastic Syndromes, Hematologic Diseases, Preleukemia

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.

Interventions

DRUGlintuzumab

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

DRUGlenalidomide

10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The incidence of adverse events and lab abnormalities	1 month after last dose

Secondary

Measure	Time frame
Antitumor activity	Every other 21-day cycle
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)	1 month after last dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026