Clinical trial · Interventional
Fludarabine Combined With Either Alemtuzumab or Rituximab in Treating Patients With Refractory or Relapsed B-Cell Chronic Lymphocytic Leukemia
Phase II Trial Comparing Combination Treatment With Fludarabine and Alemtuzumab to Fludarabine and Rituximab in Patients With B-Cell Chronic Lymphocytic Leukemia Requiring Treatment After First Line Therapy
- 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: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as alemtuzumab and rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells. It is not yet known whether fludarabine is more effective when combined with alemtuzumab or with rituximab in treating chronic lymphocytic leukemia. PURPOSE: Randomized phase II trial to compare the effectiveness of combining fludarabine with either alemtuzumab or rituximab in treating patients who have refractory or relapsed B-cell 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of B-cell chronic lymphocytic leukemia (CLL), defined as: * Peripheral lymphocyte count \> 5,000/mm\^3 * Clonal CD5-, CD19-, and CD23-positive lymphocytes * Refractory to OR relapsed after prior first-line therapy * No CNS involvement with CLL PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine ≤ 1.5 times ULN Immunologic * No active cytomegalovirus * No prior fludarabine-associated autoimmune hemolytic anemia or immune thrombocytopenic purpura * No active infection requiring treatment with antibiotic, antiviral, or antifungal agents * No prior significant allergic reaction to antibody therapies that required therapy to be discontinued * HIV negative Other * No active secondary malignancy * No other concurrent severe diseases or mental disorders * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior alemtuzumab and/or rituximab * No prior bone marrow transplantation * No concurrent thrombopoietin or pegfilgrastim Chemotherapy * More than 3 weeks since prior fludarabine Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 3 months since prior investigational drugs * No other concurrent cytotoxic therapy
References
Publications (0)
Data not yet available