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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: December 17, 2010
Last updated: May 4, 2016
Last verified: May 2016
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
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Progression-free survival (according to NCI-WG guidelines) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Quality of life: Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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
Genders Eligible for Study:   Both
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 ClinicalTrials.gov identifier: NCT01263704

Afula, Israel, 18101
Beer Sheva, Israel, 8410101
Haifa, Israel, 3109601
Haifa, Israel, 3339419
Jerusalem, Israel, 9112001
Jerusalem, Israel, 9103102
Kfar Saba, Israel, 44281
Nahariya, Israel, 22100
Petach Tikva, Israel, 49100
Rehovot, Israel, 7610000
Rishon Lezion, Israel, 70300
Tel Aviv, Israel, 6423906
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01263704     History of Changes
Other Study ID Numbers: ML25464 
Study First Received: December 17, 2010
Last Updated: May 4, 2016
Health Authority: Israel: Ministry of Health, Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on May 26, 2016