Clinical trial · Interventional
Monoclonal Antibody in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Phase I Study Of IDEC-152 (Anti-CD23 Monoclonal Antibody) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia
NCT00058396CI-TRIAL-00010495completedPhase 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)
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lumiliximab | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed chronic lymphocytic leukemia OR small lymphocytic lymphoma
* Stage III-IV OR
* Stage I-II, if determined to have disease progression evidenced by 1 of the following characteristics:
* Rapid doubling of peripheral lymphocyte count
* Progressive lymphadenopathy
* Progressive splenomegaly
* B symptoms
* Grade 2 or 3 fatigue
* CD23+ disease
* Progressive disease after at least 1 prior chemotherapy course
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* WHO 0-2
Life expectancy
* At least 6 months
Hematopoietic
* Platelet count at least 50,000/mm\^3
Hepatic
* Bilirubin no greater than 2.0 mg/dL
* AST/ALT no greater than 1.5 times upper limit of normal (ULN)
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* No New York Heart Association class III or IV cardiac disease
* No myocardial infarction within the past 6 months
* No unstable arrhythmia
* No evidence of ischemia on EKG within the past 14 days
Pulmonary
* FEV\_1 at least 60% of predicted
* DLCO at least 55% of predicted
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study treatment
* HIV negative
* No secondary malignancy requiring active treatment (except hormonal therapy)
* No serious nonmalignant disease that would preclude study participation
* No active uncontrolled bacterial, viral, or fungal infection
* No clinically active autoimmune disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior anticancer biologic therapy
* More than 4 weeks since prior anticancer radioimmunotherapy
* No prior exposure to IDEC-152 or anti-CD23 antibodies
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior anticancer chemotherapy
Endocrine therapy
* Concurrent hormonal therapy allowed for second malignancy
Radiotherapy
* More than 4 weeks since prior anticancer radiotherapy
Surgery
* More than 4 weeks since prior major surgery (except for diagnostic surgery)
Other
* More than 4 weeks since prior anticancer investigational therapy
* No other concurrent anticancer therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.