Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia

NCT ID: NCT02461316

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-12-31

Brief Summary

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

Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).

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, Chronic Lymphocytic Leukemia, Cancer

Study Design

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

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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

Combination Treatment in Chronic Lymphocytic Leukemia (CLL)

All participants receiving combination treatment in Chronic Lymphocytic Leukemia (CLL)

No intervention

Intervention Type OTHER

No intervention administered in this study: Rituximab in combination with fludarabine and cyclophosphamide for 6 months according to registered indication.

Interventions

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

No intervention

No intervention administered in this study: Rituximab in combination with fludarabine and cyclophosphamide for 6 months according to registered indication.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Patients older than 18 years with diagnosed Chronic Lymphocytic Leukemia (CLL)
* CLL stages: Binet stage C (Rai III or IV), Binet stage B (Rai I and II) requiring treatment

Exclusion Criteria

\- Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Belgrade, , Serbia

Site Status

Kragujevac, , Serbia

Site Status

Novi Sad, , Serbia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Serbia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ML25066

Identifier Type: -

Identifier Source: org_study_id