Clinical trial · Interventional
Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)
A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia
NCT00593944CI-TRIAL-00010386MDX1342-02completedPhase 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)
The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDX-1342 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Patients will receive active MDX-1342.
- interventionNames
- Biological: MDX-1342
Primary outcomes (1)
- measure
- incidence and severity of treatment-emergent adverse events
- timeFrame
- all events will be followed to resolution
Secondary outcomes (6)
- measure
- response
- timeFrame
- 12 weeks
- measure
- clinical laboratory tests
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * relapsed/refractory CD19-positive CLL * At least 28 days since prior treatment for CLL * ECOG PS 0-2 * Screening laboratory values must be met Exclusion Criteria: * No prior anti-CD19 antibody tx * No active, uncontrolled infection * No prior allogeneic bone marrow transplant * No autoimmune disease
References
Publications (0)
Data not yet available
No reference posted for this study.