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Lymphocytic Leukemia, ChronicNCT01224093

An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)

An observational study of Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 55 sites in Spain.

Completed

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

Official record
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Trial summary

This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphocytic Leukemia, Chronic
What is being tested?
Chemotherapy and rituximab [MabThera/Rituxan]
How many people
219 participants
Where
55 sitesSpain
Study dates
Oct 2010to Feb 2014
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 B cell-lineage chronic lymphocytic leukaemia (B-CLL)

Who may be able to join

  • Adult patients, >/= 18 years of age
  • B cell-lineage chronic lymphocytic leukaemia (B-CLL)
  • Prescribed with MabThera/Rituxan in combination with chemotherapy according to the approved SMPC
  • Informed consent to data collection

Who cannot join

  • Treatment with any marketed or non-marketed drug substance or experimental therapy within 4 weeks prior to first dose of study drug or participation in a clinical trial within 30 days prior to entering this study
  • Any other tumour disease

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

Spain55 sites

  • Study site

    Alcorcón, Madrid, 28922

  • Study site

    Alicante, Alicante, 03010

  • Study site

    Almería, Almeria, 04009

  • Study site

    Alzira, Valencia, 46600

  • Study site

    Badalona, Barcelona, 08915

  • Study site

    Barcelona, Barcelona, 08025

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08907

  • Study site

    Bilbao, Vizcaya, 48013

  • Study site

    Cadiz, Cadiz, 11009

  • Study site

    Cartagena, Murcia, 30203

  • Study site

    Castellon, Castellon, 12004

  • Study site

    Elche, Alicante, 03203

  • Study site

    Ferrol, La Coruña, 15405

  • Study site

    Gijón, Principality of Asturias, 33203

  • Study site

    Girona, Girona, 17007

  • Study site

    Huelva, Huelva, 21005

  • Study site

    Jaén, Jaen, 23007

  • Study site

    Jerez de la Frontera, Cadiz, 11407

  • Study site

    Las Palmas, Las Palmas, 35020

  • Study site

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • Study site

    León, Leon, 24071

  • Study site

    Lleida, Lerida, 25198

  • Study site

    Logroño, La Rioja, 26006

  • Study site

    Lorca, Murcia, 30800

  • Study site

    Madrid, Madrid, 28007

  • Study site

    Madrid, Madrid, 28031

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Madrid, Madrid, 28046

  • Study site

    Madrid, Madrid, 28222

  • Study site

    Madrid, Madrid, 28905

  • Study site

    Málaga, Malaga, 29010

  • Study site

    Málaga, Malaga, 29600

  • Study site

    Oviedo, Principality of Asturias, 33011

  • Study site

    Palma de Mallorca, Balearic Islands, 07014

  • Study site

    Palma de Mallorca, Balearic Islands, 07198

  • Study site

    Pamplona, Navarre, 31008

  • Study site

    Puerto Real, Cadiz, 11510

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    San Cristóbal de La Laguna, Tenerife, 38320

  • Study site

    Santa Cruz de Tenerife, Tenerife, 38010

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Seville, Sevilla, 41009

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Seville, Sevilla, 41014

  • Study site

    Tarragona, Tarragona, 43007

  • Study site

    Valencia, Valencia, 46010

  • Study site

    Valencia, Valencia, 46014

  • Study site

    Valencia, Valencia, 46017

  • Study site

    Valencia, Valencia, 46026

  • Study site

    Valladolid, Valladolid, 47010

  • Study site

    Vitoria-Gasteiz, Alava, 01009

  • Study site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: A Multicentre, Observational, Prospective Study to Assess the Safety Profile of Rituximab in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (B-CLL)

This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.

Being tested
Chemotherapy, rituximab [MabThera/Rituxan]
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.

  • ChemotherapyDrug

    as prescribed

  • rituximab [MabThera/Rituxan]Drug

    as prescribed

Study groups in NCT01224093
Study groupRoleWhat they receive
First lineNot described
Receives: Drug: Chemotherapy; Drug: rituximab [MabThera/Rituxan]
Relapsed/refractoryNot described
Receives: Drug: Chemotherapy; Drug: rituximab [MabThera/Rituxan]

What is being measured

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

  1. Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients

    Measured: 3 years

Secondary outcomes (3)

  1. Efficacy (Response rate, duration of response, progression-free survival)

    Measured: 3 years

  2. Chronic lymphocytic leukaemia (CLL) Comorboid Scale

    Measured: 3 years

  3. Quality-adjusted survival analysis (Q-TWIST methodology)

    Measured: 3 years

Timeline

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

  1. First posted19 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

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
Cohort
Time perspective
Prospective
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01224093
Sponsor's protocol ID
ML25372
Status last verified
Nov 2016
First submitted
18 Oct 2010
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 55 sites in Spain.

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 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Spain. 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?

Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients (time frame: 3 years). 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 NCT01224093.

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 2 Nov 2016.

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