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

May 30, 2017 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • National Institute of Oncology, A Dept of Internal Medicine
      • Budapest, Hungary, 1083
        • Semmelweis University, First Dept of Medicine
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum; III. Belgyogyaszati Klinika
      • Eger, Hungary, 3300
        • Markhot Ferenc Oktato Korhaz es Rendelointezet; III. belgyogyaszat
      • Gyula, Hungary, 5700
        • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza; I. Belgyogyaszat-Hematologia Reszle
      • Miskolc, Hungary, 3529
        • Miskolci Semmelweis Kórház és Egyetemi Oktatókórház; Haematology Dept.
      • Nyíregyháza, Hungary, 4400
        • Josa Andras Korhaz; Ii. Sz. Belgyogyaszati Es Haematologiai Osztaly
      • Pecs, Hungary, 7624
        • University of Pecs, I st Dept of Internal Medicine
      • Szeged, Hungary, 6720
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
      • Szolnok, Hungary, 5004
        • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály
      • Szombathely, Hungary, 9700
        • Vas Megyei Markusovszky Korhaz; Haematologiai Osztaly
      • Székesfehérvár, Hungary, 8000
        • Fejér Megyei Szent György Kórház; Hematologiai Osztaly
      • Tatabanuya, Hungary, 2800
        • Szent Borbala Korhaz
      • Veszprem, Hungary, 8200
        • Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with untreated chronic lymphocytic leukemia (CLL)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CLL patients on Mabthera (rituximab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (ORR) as assessed by the investigator using routine assessment techniques
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ORR analysed according to concomitant chemotherapy
Time Frame: 7 months
7 months
ORR analysed according to age
Time Frame: 7 months
7 months
ORR analysed according to CIRS score
Time Frame: 7 months
7 months
ORR analysed according to certain chromosomal abnormalities
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2014

Primary Completion (Actual)

December 19, 2016

Study Completion (Actual)

December 19, 2016

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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