Clinical trial · Interventional
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia
NCT00055146CI-TRIAL-00002219completedPhase 2ClinicalTrials.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 evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)
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 |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONTAK | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective Clinical Response
Secondary outcomes (2)
- measure
- Time-to-Progression
- measure
- Duration of response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with B-cell Chronic Lymphocytic Leukemia, Rai Stage 0-II with indication for treatment by NCI Working Group Criteria or Rai Stage III or IV. * Patients must have received at least one prior purine analogue-based chemotherapy regimen. * ECOG Performance Status of 0, 1, or 2. * Female patients cannot be pregnant and must use birth control during the course of the study and for three weeks after the study ends. Exclusion Criteria: * Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2. * Received any therapy for CLL within 35 days prior to study entry.
References
Publications (0)
Data not yet available
No reference posted for this study.