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

Lymphocytic Leukemia, Chronic Clinical Trial

Official title:

A Multicenter, Single-arm, Phase II Study to Evaluate the Efficacy and Safety of Rituximab Plus Fludarabine and Cyclophosphamide (FCR) as First-line Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533401
• Other study ID #: ML18429
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2015
• Last updated: November 2, 2015
• Start date: February 2006
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy in participants with B-cell CLL. The anticipated time on study treatment is 6 months, and the target sample size is 30 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants greater than or equal to (>=) 18 years of age

• B-cell CLL

• No previous treatment for leukemia

Exclusion Criteria:

• History of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer

• Comorbid condition requiring long-term (greater than [>] 1 month) systemic corticosteroids during study treatment

• Known infection with hepatitis B or C virus or with human immunodeficiency virus (HIV)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytic Leukemia, Chronic

Intervention

Drug:
• Cyclophosphamide
Cyclophosphamide will be administered IV at 250 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.
• Fludarabine
Fludarabine will be administered IV at 25 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.
• Rituximab
Rituximab will be administered IV at 375 mg/m^2 on Day 1 of Cycle 1 and then at 500 mg/m^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		Up to 5 years	No
Primary	Overall survival		Up to 5 years	No
Primary	Objective response rate		Up to 5 years	No
Secondary	Incidence of adverse events		Up to 7 months	No