Clinical trial · Interventional
Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia
- 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 such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Combining monoclonal antibody therapy, chemotherapy, radiation therapy, and peripheral stem cell transplantation may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of alemtuzumab plus peripheral stem cell transplantation 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of chronic lymphocytic leukemia (CLL) that meets the following criteria at any point prior to study entry: * Peripheral blood absolute blood count greater than 5,000/mm\^3 * Lymphocytosis must comprise small to moderate size lymphocytes with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically * Phenotypically characterized B-cell CLL * Splenomegaly, hepatomegaly, or lymphadenopathy not required for CLL diagnosis * Must have bone marrow biopsy within 4 weeks of study entry showing cellularity of at least 25% of intratrabecular space and lymphocytes accounting for no more than 30% of nucleated cells PATIENT CHARACTERISTICS: Age: * 18 to 65 Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * Absolute neutrophil count at least 1,000/mm\^3 * Hemoglobin at least 11 g/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2 mg/dL (unless secondary to tumor) * AST or ALT less than 3 times upper limit of normal * Hepatitis B surface antigen negative * Hepatitis C RNA negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * Left ventricular ejection fraction at least 45% by echocardiogram or MUGA Pulmonary: * DLCO, FEV\_1, and FVC greater than 50% of predicted Other: * No active infection requiring oral or IV antibiotics * No other prior malignancy within the past two years except basal cell skin cancer or carcinoma in situ of the cervix * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior monoclonal antibody CD52 allowed if at least partial remission was achieved with last treatment Chemotherapy: * No more than 2 prior chemotherapy regimens * At least 3 weeks since prior chemotherapy * No more than 8 courses of prior fludarabine therapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (0)
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