Clinical trial · Interventional
Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)
A Phase I Multicenter, Dose-Escalation Study of IDEC-152 (Anti-CD23 Monoclonal Antibody) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT00046488CI-TRIAL-00012068completedPhase 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)
To determine what side effects and what clinical effects if any the administration of this investigational product, IDEC-152 (an antibody against CD23 which is an important protein on leukemia cells and certain cells in the body's immune system), has on the CLL patient population.
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 |
|---|---|---|---|
| IDEC-152 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL
- timeFrame
- 48 months
- measure
- Characterize the safety profile of IDEC-152
- timeFrame
- 48 months
Secondary outcomes (2)
- measure
- Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL
- timeFrame
- 48 months
- measure
- Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL
- timeFrame
- 48 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed IRB-approved informed consent. * Greater than 18 years of age * Proof of CD23+ CLL or small lymphocytic lymphoma (SLL) * Progressive disease after at least 1 course of chemotherapy * Acceptable hematologic status, liver function, renal function, and pulmonary function * Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment Exclusion Criteria: * Previous exposure to IDEC-152 or other anti-CD23 antibodies * Presence of HIV infection or AIDS * Serious nonmalignant disease * Active uncontrolled bacterial, viral or fungal infections. * Clinically active autoimmune disease * Pregnant or currently breast feeding
References
Publications (2)
- BACKGROUNDByrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55. doi: 10.1158/1078-0432.CCR-06-1463. PMID 17671129
- BACKGROUNDPathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. doi: 10.1182/blood-2007-03-082024. Epub 2007 Nov 21. PMID 18032710