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Completed

NCT Number: NCT02080884

An Observational Study Examining the Effect of Added MabThera Therapy in Patients With Untreated Chronic Lymphocytic Leukemia

This study will examine the effectiveness of MabThera therapy added to a standard chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Patients who have received a single prior MabThera plus chemotherapy treatment are eligible. The overall response rate of patients treated for approximately 5 months (as per current label guidelines) will be analysed according to various factors (i.e., age, concurrent treatment, and chromosomal abnormalities).

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Oncology, A Dept of Internal Medicine, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with first-line CLL having received only 1 cycle of MabThera chemotherapy
  • aged >/= 18 years

Exclusion criteria

  • Pregnant or breast-feeding
  • Receipt of an investigational drug within 30 days prior to entering the study

Treatment and study plan

Primary outcomes

  1. Overall response rate (ORR) as assessed by the investigator using routine assessment techniques

    Time frame: 7 months

Secondary outcomes

  1. ORR analysed according to concomitant chemotherapy

    Time frame: 7 months

  2. ORR analysed according to age

    Time frame: 7 months

  3. ORR analysed according to CIRS score

    Time frame: 7 months

  4. ORR analysed according to certain chromosomal abnormalities

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A MULTICENTER NON-INTERVENTIONAL STUDY EVALUATING THE BENEFIT OF THE COMBINATION OF MABTHERA (RITUXIMAB) WITH STANDARD CHEMOTHERAPEUTIC REGIMENS IN PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN HUNGARY

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2014
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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