AzTrials
AzTrials

Chronic Lymphocytic LeukemiaNCT02080884

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

An observational study of Chronic Lymphocytic Leukemia, run by Hoffmann-La Roche at 15 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
How many people
150 participants
Where
15 sitesHungary
Study dates
24 Jun 2014to 19 Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with untreated chronic lymphocytic leukemia (CLL)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Hungary15 sites

  • Semmelweis University, First Dept of Medicine

    Budapest, 1083

  • National Institute of Oncology, A Dept of Internal Medicine

    Budapest, 1122

  • Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

    Budapest, 1125

  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum; III. Belgyogyaszati Klinika

    Debrecen, 4032

  • Markhot Ferenc Oktato Korhaz es Rendelointezet; III. belgyogyaszat

    Eger, 3300

  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza; I. Belgyogyaszat-Hematologia Reszle

    Gyula, 5700

  • Miskolci Semmelweis Kórház és Egyetemi Oktatókórház; Haematology Dept.

    Miskolc, 3529

  • Josa Andras Korhaz; Ii. Sz. Belgyogyaszati Es Haematologiai Osztaly

    Nyíregyháza, 4400

  • University of Pecs, I st Dept of Internal Medicine

    Pécs, 7624

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

    Szeged, 6720

  • Fejér Megyei Szent György Kórház; Hematologiai Osztaly

    Székesfehérvár, 8000

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály

    Szolnok, 5004

  • Vas Megyei Markusovszky Korhaz; Haematologiai Osztaly

    Szombathely, 9700

  • Szent Borbala Korhaz

    Tatabanuya, 2800

  • Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.

    Veszprém, 8200

Other trials in Hungary

About this study

Official 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

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).

Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02080884
Study groupRoleWhat they receive
CLL patients on Mabthera (rituximab)Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 7 months

Secondary outcomes (4)

  1. ORR analysed according to concomitant chemotherapy

    Measured: 7 months

  2. ORR analysed according to age

    Measured: 7 months

  3. ORR analysed according to CIRS score

    Measured: 7 months

  4. ORR analysed according to certain chromosomal abnormalities

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2014 (estimated)
  2. Study start24 Jun 2014
  3. Primary completion19 Dec 2016
  4. Study completion19 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02080884
Sponsor's protocol ID
ML29201
Status last verified
May 2017
First submitted
5 Mar 2014
Last updated
31 May 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia, run by Hoffmann-La Roche at 15 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) as assessed by the investigator using routine assessment techniques (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02080884.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in