Clinical trial · Interventional
A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status
Prospective Study of Efficacy and Safety of RFC (Rituximab, Fludarabine, Cyclophosphamide) Regimen as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Favorable Somatic Status
NCT01271010CI-TRIAL-00032135terminatedPhase 4Results postedClinicalTrials.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)
This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.
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 |
|---|---|---|---|
| Lymphocytic Leukemia, Chronic | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab + Fludarabine + Cyclophosphamide
- description
- Participants received rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m\^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m\^2 IV or 40 mg/m\^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m\^2 IV or 250 mg/m\^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Rituximab
Primary outcomes (10)
- measure
- Percentage of Participants With Complete Remission
- timeFrame
- Up to approximately 5 years
- description
- Complete remission was defined as the disappearance of all signs of disease.
- measure
- Percentage of Participants With Disease Progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of previously untreated B-cell CLL confirmed immunophenotypically * For participants, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity score less than or equal to (\</=) 6 * Binet stage B, C or A with progression * Life expectancy greater than or equal to (\>/=) 12 months * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 * Women of child bearing potential and men should agree to use highly reliable contraceptive method throughout the treatment period and within 12 months after treatment completion Exclusion Criteria: * Participants with small-cell lymphoma * Participants with auto-immune hemolytic anemia * Concomitant malignant disease during enrollment, except basal cell carcinoma of the skin * Chemotherapy for concomitant malignant disease given within 12 months prior to study enrollment * Participants with Richter's Syndrome * Participants with symptomatic Hepatitis B infection * Any clinically significant infection that could not be cured prior to enrollment, including Human Immunodeficiency Virus (HIV) infection * Creatinine clearance less than (\<) 30 milliliters per minute (mL/min) * Participants with congestive heart failure (CHF) New York Heart Association (NYHA) III-IV * Participants with liver failure and acute hepatitis of any etiology * Any other medical or mental condition which may preclude from receiving the entire course of protocol specified treatment or signing the informed consent * History of an anaphylactic reaction to murine antibodies, proteins, or any other ingredient of rituximab * Pregnancy and breast-feeding women
References
Publications (0)
Data not yet available
No reference posted for this study.