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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-17

Study Completion Date

2017-04-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia

NCT01292603

Lymphocytic Leukemia, Chronic

COMPLETED PHASE1

A Study of Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

NCT02533401

Lymphocytic Leukemia, Chronic

COMPLETED PHASE2

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

NCT01271010

Lymphocytic Leukemia, Chronic

TERMINATED PHASE4

Rituximab Maintenance Versus Observation After First-line Immunochemotherapy by FCR in Older Patients With Chronic Lymphocytic Leukemia

NCT00645606

Leukemia

COMPLETED PHASE3

A Study of MabThera (Rituximab) Plus Chlorambucil in Participants With Chronic Lymphocytic Leukemia.

NCT00532129

Lymphocytic Leukemia, Chronic

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphocytic Leukemia, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rituximab plus Fludarabine and Cyclophosphamide

Elderly participants with chronic lymphocytic leukemia (CLL) will receive combination treatment with low-dose fludarabine and cyclophosphamide combined with standard-dose of rituximab for 6 months. Treatment is followed by a follow up period of 36 months.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

150 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1-3 of each 28-day cycle for 6 cycles

Fludarabine

Intervention Type DRUG

12.5 mg/m\^2 IV on Days 1-3 of every 28-day cycle for 6 cycles

Rituximab

Intervention Type DRUG

375 mg/m\^2 IV Day 0 of Cycle 1, 500 mg/m\^2 IV Day 1 of Cycles 2-6. Each cycle was 28 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cyclophosphamide

150 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1-3 of each 28-day cycle for 6 cycles

Intervention Type DRUG

Fludarabine

12.5 mg/m\^2 IV on Days 1-3 of every 28-day cycle for 6 cycles

Intervention Type DRUG

Rituximab

375 mg/m\^2 IV Day 0 of Cycle 1, 500 mg/m\^2 IV Day 1 of Cycles 2-6. Each cycle was 28 days.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MabThera/Rituxan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No