Status:
COMPLETED
A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Lymphocytic Leukemia, Chronic
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2017
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01263704
Start Date
July 17 2011
End Date
April 3 2017
Last Update
April 23 2018
Active Locations (12)
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1
Haemek Medical Center; Hematology Department
Afula, Israel, 18101
2
Soroka Medical Center; Hematology Deptartment
Beersheba, Israel, 8410101
3
Rambam Medical Center; Heamatology & Bone Marrow Transplantation
Haifa, Israel, 3109601
4
Bnei-Zion Medical Center; Hematology Dept
Haifa, Israel, 3339419