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A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: December 17, 2010
Last updated: April 19, 2017
Last verified: April 2017
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.

Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: cyclophosphamide
Drug: fludarabine
Drug: rituximab [MabThera/Rituxan]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Single Arm Study to Determine the Efficacy and Safety of Low Dose Fludarabine and Cyclophosphamide Combined With Standard Dose Rituximab as Primary Therapy in Elderly Untreated Patients (>/=65 Years Old) With Chronic Lymphocytic Leukemia

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall Response Rate (according to National Cancer Institute - Working Group [NCI-WG] guidelines) [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events (especially neutropenic fever, infection rate, number of hospitalization days, thrombocytopenia >/= grade 3, neutropenia >/= grade 3)) [ Time Frame: 5 years ]
  • Progression-free survival (according to NCI-WG guidelines) [ Time Frame: up to 36 months ]
  • Quality of life: Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire [ Time Frame: up to 36 months ]

Enrollment: 42
Actual Study Start Date: July 17, 2011
Study Completion Date: April 3, 2017
Primary Completion Date: April 3, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: cyclophosphamide
150 mg/m2 on Days 1-3 of each 28-day cycle, 6 cycles
Drug: fludarabine
12.5 mg/m2 on Days 1-3 of every 28-day cycle, 6 cycles
Drug: rituximab [MabThera/Rituxan]
375 mg/m2 iv Day 0 of Cycle 1, 500 mg/m2 iv Day 1 of Cycles 2-6


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 CNS involvement of CLL
  • Impaired renal or hepatic function
  • HIV positivity, active hepatitis B/C or 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 HBVsAg (either anti-HBS Ab positive or negative) and are positive for HBV-DNA by 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)
  • ECOG performance status >/= 3
  Contacts and Locations
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Please refer to this study by its identifier: NCT01263704

Haemek Medical Center; Hematology Department
Afula, Israel, 18101
Soroka Medical Center; Hematology Deptartment
Beer Sheva, Israel, 8410101
Rambam Medical Center; Heamatology & Bone Marrow Transplantation
Haifa, Israel, 3109601
Bnei-Zion Medical Center; Hematology Dept
Haifa, Israel, 3339419
Shaare Zedek Medical Center; Hematology Dept.
Jerusalem, Israel, 9103102
Hadassah Ein Karem Hospital; Haematology
Jerusalem, Israel, 9112001
Meir Medical Center; Internal Dept A
Kfar Saba, Israel, 44281
Western Galilee Hospital - Nahariya
Nahariya, Israel, 22100
Beilinson Medical Center; Haematology
Petach Tikva, Israel, 49100
Kaplan Medical Center
Rehovot, Israel, 7661041
ASSAF Harofe; Department of Hematology
Rishon Lezion, Israel, 70300
Ichilov Sourasky Medical Center; Heamatology
Tel Aviv, Israel, 6423906
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01263704     History of Changes
Other Study ID Numbers: ML25464
Study First Received: December 17, 2010
Last Updated: April 19, 2017

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents processed this record on April 26, 2017