A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01271010
• Date of registration: 04/01/2011
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status
• Scientific title: 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
• Date of first enrolment: June 2011
• Target sample size: 89
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01271010
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Russian Federation

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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 (
- 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphocytic Leukemia, Chronic

Intervention(s)

Drug: Fludarabine

Drug: Cyclophosphamide

Drug: Rituximab

Primary Outcome(s)

Percentage of Participants with Primary Resistance to Therapy [Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months)]

Progression-Free Survival as Assessed by the Investigator Based on Physical Examination, Hematology, ECOG PS, and Radiology [Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months)]

Duration of Response as Assessed by the Investigator Based on Physical Examination, Hematology, ECOG PS, and Radiology [Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months)]

Event-Free Survival as Assessed by the Investigator Based on Physical Examination, Hematology, ECOG PS, and Radiology [Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months)]

Percentage of Participants With Therapy Response (Complete Remission, Partial Remission, Stable Disease, and Disease Progression) as Assessed by the Investigator Based on Physical Examination, Hematology, ECOG PS, and Radiology [Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months)]

Percentage of Participants Who Achieved Minimal Residual Disease (MRD) Negativity [Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months)]

Overall Survival [Time Frame: Baseline until death due to any cause (up to approximately 60 months)]

Percentage of Participants with Adverse Events [Time Frame: Baseline up to approximately 60 months]

Secondary ID(s)

ML25136

Source(s) of Monetary Support

Please refer to primary and secondary sponsors