Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia
PHASE I STUDY OF T-CELL LARGE GRANULAR LYMPHOCYTIC LEUKEMIA USING THE MIK-BETA 1 MONOCLONAL ANTIBODY DIRECTED TOWARD THE IL-2R BETA SUBUNIT
NCT00019032CI-TRIAL-00017667completedPhase 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 cancer cells and either kill them or deliver cancer-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 chronic lymphocytic leukemia.
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 | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| monoclonal antibody Mik-beta-1 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed T-cell large granular lymphocytic (T-LGL) leukemia associated with clinically significant hematocytopenia demonstrated by one of the following values while off growth factor support: * Absolute neutrophil count less than 1,000/mm\^3 * Hemoglobin less than 8 g/dL * Platelet count less than 50,000/mm\^3 * Clinically evaluable disease with peripheral blood T-LGL leukemia cells expressing the CD3+, CD8+ phenotype detectable by FACS * Monoclonal T-cell population in peripheral blood (circulating mononuclear cells) demonstrated by TCR beta or gamma chain gene rearrangement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 50-100% Life expectancy: * More than 2 months Hematopoietic: * See Disease Characteristics * No active major bleeding episode within the past 4 weeks Hepatic: * Direct bilirubin less than 1.5 mg/dL Renal: * Creatinine less than 2.0 mg/dL Other: * No concurrent serious active infection * Patients with fever without apparent site of infection may begin study while on antibiotics as long as the following are true: * No pathogenic organism in culture * Afebrile (maximum temperature less than 38°C) for at least 5 days * HIV negative * No other primary cancer other than basal cell skin cancer * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior interferon * Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), interleukin-11, or similar sustained-release/long-acting product (e.g., pegylated G-CSF) allowed if dose established at least 4 weeks prior to study participation * No concurrent interferon Chemotherapy: * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * Concurrent corticosteroids allowed if dose established at least 3 weeks prior to study participation Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 1 week since completion of prior antibiotic regimen for serious infectious episode * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.