Clinical trial · Interventional
Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia
NCT00049075CI-TRIAL-00044467completedPhase 2ClinicalTrials.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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of fludarabine in treating patients who have chronic lymphocytic leukemia that has not been previously treated.
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 |
|---|---|---|---|
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) * Previously untreated * Rai stage I, II, III, or IV * Requiring systemic therapy * Persistent lymphocytosis of greater than 5,000/mm\^3 * Morphologically mature lymphocytes * Monoclonal B-cell population * CD19/CD5/CD23 positive with kappa or lambda light chain restriction by immunophenotyping * No other lymphoproliferative disorders including prolymphocytic leukemia, mantle cell lymphoma, progression to aggressive B-cell lymphoma, or Richter's syndrome * No clinical autoimmune hematologic complication of CLL including Coomb's-positive hemolytic anemia or immune thrombocytopenia * Positive Coomb's test allowed if no clinical hemolysis PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * See Disease Characteristics Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and/or ALT no greater than 2 times ULN Renal * Creatinine no greater than 2 times ULN Other * Accessible for treatment and follow-up * No known HIV infection * No active bacterial, viral, or fungal infection requiring systemic antibiotics * No conditions requiring corticosteroid therapy * No history of other malignancies except for the following: * Adequately treated nonmelanoma skin cancer * Curatively treated carcinoma in situ of the cervix * Other solid tumors curatively treated with no evidence of disease within the past 5 years * No other major medical illness that would preclude study * No known hypersensitivity to fludarabine or its components * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy including monoclonal antibody therapy * No concurrent autologous or allogeneic stem cell or bone marrow transplantation Chemotherapy * No other concurrent cytotoxic drugs Endocrine therapy * No concurrent corticosteroids except inhaled or topical corticosteroids * No concurrent corticosteroids for nausea prophylaxis Radiotherapy * No prior radiotherapy affecting more than 25% of bone marrow and/or involving the pelvic area * No concurrent radiotherapy Surgery * Not specified Other * At least 4 weeks since prior investigational agents * No other concurrent investigational agents
References
Publications (1)
- RESULTShustik C, Turner AR, Desjardins P, Fernandez L, Rubin S, Larratt L, Duncan AM, Rizi D, Sadura A, Shepherd L, Li D, Rassenti L, Kipps T. Oral fludarabine in untreated patients with B-cell chronic lymphocytic leukemia. Leukemia. 2010 Jan;24(1):237-9. doi: 10.1038/leu.2009.205. Epub 2009 Oct 8. No abstract available. PMID 19812607