Clinical trial · Interventional
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)
NCT00502112CI-TRIAL-00005617completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
| lintuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- lintuzumab and lenalidomide
- interventionNames
- Drug: lintuzumab
- Drug: lenalidomide
Primary outcomes (1)
- measure
- The incidence of adverse events and lab abnormalities
- timeFrame
- 1 month after last dose
Secondary outcomes (2)
- measure
- Antitumor activity
- timeFrame
- Every other 21-day cycle
- measure
- Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.