Phase 2
Completed N=42
A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia
Lymphocytic Leukemia, Chronic
Source: ClinicalTrials.gov NCT01263704 ↗
Enrolled (actual)
42
Serious AEs
45.2%
Results posted
Apr 2018
Primary outcomePrimary: Overall Response Rate — 67.5 percentage of participants
Summary
This single arm, open-label study will assess the safety and efficacy of low dose fludarabine and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as primary therapy in elderly patients (>/= 65 years) with chronic lymphocytic leukemia. Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2 intravenously [iv] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5 mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6). Anticipated time on study treatment is 6 months, with a 30-month follow-up period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
67.5 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
97.6; 45.2 | — |
| SECONDARY Percentage of Participants With Neutropenic Fever, Infection, >/= Grade 3 Drug-Related Neutropenia, >/= Grade 3 Drug-Related Thrombocytopenia, Hospitalizations |
47.6; 14.3; 47.6; 11.9; 19.1 | — |
| SECONDARY Hospitalization Days |
8 | — |
| SECONDARY Progression-free Survival (PFS) |
36.1 | — |
| SECONDARY Quality of Life (QoL): Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Questionnaire |
36.1; 39.4; 40.2; 47.0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 65 years of age
- Previously untreated B-cell chronic lymphocytic leukemia (CLL)
- Binet stage C or active Binet stage A and B disease
Exclusion Criteria
- Prior treatment for CLL
- CLL with transformation (Richter's syndrome)
- Suspected or known central nervous system (CNS) involvement of CLL
- Impaired renal or hepatic function
- Human Immunodeficiency Virus (HIV) positivity, active hepatitis B/C or Hepatitis B Virus (HBV) surface antigen positive, or any active or uncontrolled infections
- Patients with anti-HBV core antibodies (past infection with HBV) but who are negative for Hepatitis B Virus Surface Antigen (HBVsAg) (either anti-HBS Ab positive or negative) and are positive for HBV- Deoxyribonucleic acid (DNA) by Polymerase chain reaction (PCR) analysis
- Concomitant diseases requiring chronic steroid administration
- Active second malignancy within the 2 years prior to study (except for non-melanoma skin cancer and in situ cervix or breast or prostate carcinoma)
- Eastern Cooperative Oncology Group (ECOG) performance status >/= 3
Data sourced from ClinicalTrials.gov (NCT01263704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.