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Lymphocytic Leukemia, ChronicNCT01488162

An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia

An observational study of Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 84 sites in France.

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 multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphocytic Leukemia, Chronic
How many people
327 participants
Where
84 sitesFrance
Study dates
4 Apr 2011to 24 Oct 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: Adult patients with relapsing or refractory chronic lymphocytic leukemia (CLL)

Who may be able to join

  • Adult patients, >/=18 years of age
  • Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) with first or second relapse
  • Previous treatment with MabThera/Rituxan
  • MabThera/Rituxan treatment planned for current relapse

Who cannot join

  • Richter syndrome
  • Life expectancy <6 months

Trial locations and contacts

84 sites in 1 country.

84 sites in 1 country

France84 sites

  • Study site

    Aix-en-Provence, 13616

  • Study site

    Aix-en-Provence, 13617

  • Study site

    Albi, 81030

  • Study site

    Angers, 49933

  • Study site

    Antibes, 06600

  • Study site

    Argenteuil, 95107

  • Study site

    Arras, 62022

  • Study site

    Avignon, 84902

  • Study site

    Bayonne, 64109

  • Study site

    Béziers, 34525

  • Study site

    Béziers, 34535

  • Study site

    Blois, 41016

  • Study site

    Bobigny, 93009

  • Study site

    Bordeaux, 33030

  • Study site

    Bordeaux, 33077

  • Study site

    Boulogne, 62321

  • Study site

    Bourg-en-Bresse, 01012

  • Study site

    Brest, 29609

  • Study site

    Caen, 14033

  • Study site

    Caen, 14076

  • Study site

    Carcassonne, 11890

  • Study site

    Castelnau Lez, 34170

  • Study site

    Chalon-sur-Saône, 71321

  • Study site

    Chambéry, 73011

  • Study site

    Clermont-Ferrand, 63003

  • Study site

    Clermont-Ferrand, 63050

  • Study site

    Colmar, 68024

  • Study site

    Compiègne, 60321

  • Study site

    Corbeil-Essonnes, 91000

  • Study site

    Creil, 60109

  • Study site

    Fréjus, 83608

  • Study site

    Grenoble, 38000

  • Study site

    La Source, 45100

  • Study site

    La Tronche, 38700

  • Study site

    Le Mans, 72037

  • Study site

    Libourne, 33505

  • Study site

    Lyon, 69338

  • Study site

    Mâcon, 71018

  • Study site

    Marseille, 13005

  • Study site

    Marseille, 13291

  • Study site

    Melun, 77011

  • Study site

    Metz, 57038

  • Study site

    Metz, 57045

  • Study site

    Metz-Tessy, 74370

  • Study site

    Montauban, 82013

  • Study site

    Montpellier, 34295

  • Study site

    Mulhouse, 68070

  • Study site

    Nantes, 44093

  • Study site

    Nantes, 44202

  • Study site

    Nice, 06189

  • Study site

    Nice, 06202

  • Study site

    Nîmes, 30029

  • Study site

    Paris, 75181

  • Study site

    Paris, 75475

  • Study site

    Paris, 75571

  • Study site

    Paris, 75651

  • Study site

    Paris, 75679

  • Study site

    Perpignan, 66012

  • Study site

    Perpignan, 66046

  • Study site

    Pessac, 33604

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Poitiers, 86021

  • Study site

    Pontoise, 95300

  • Study site

    Reims, 51092

  • Study site

    Rennes, 35000

  • Study site

    Rennes, 35033

  • Study site

    Roubaix, 59056

  • Study site

    Rouen, 76038

  • Study site

    Saint Prient En Jarez, 42271

  • Study site

    Saint-Brieuc, 22027

  • Study site

    Saint-Germain-en-Laye, 78105

  • Study site

    Saint-Herblain, 44805

  • Study site

    Saint-Quentin, 02321

  • Study site

    Salon-de-Provence, 13658

  • Study site

    Salouël, 80480

  • Study site

    Strasbourg, 67091

  • Study site

    Strasbourg, 67098

  • Study site

    Toulon, 83041

  • Study site

    Toulon, 83056

  • Study site

    Toulouse, 31059

  • Study site

    Tours, 37044

  • Study site

    Troyes, 10003

  • Study site

    Valence, 26953

  • Study site

    Villejuif, 94804

Other trials in France

About this study

Official title: Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera

This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years.

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 NCT01488162
Study groupRoleWhat they receive
CohortNot described

What is being measured

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

  1. Chemotherapy regimens associated with MabThera/Rituxan in management of relapse/refractory CLL: Percentage of patients receiving purine analogues/bendamustine/alkylating agents/other chemotherapy

    Measured: 2 years

Secondary outcomes (9)

  1. Overall response rate

    Measured: 2 years

  2. Complete response rate

    Measured: 2 years

  3. Progression-free survival

    Measured: 2 years

  4. Time to next treatment

    Measured: 2 years

  5. Overall survival

    Measured: 2 years

  6. Safety (incidence of adverse events)

    Measured: 2 years

  7. Safety (incidence of hematologic adverse events)

    Measured: 2 years

  8. Safety (incidence of infections)

    Measured: 2 years

  9. Safety (incidence of secondary malignancies)

    Measured: 2 years

Timeline

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

  1. First posted8 Dec 2011 (estimated)
  2. Study start4 Apr 2011
  3. Primary completion24 Oct 2016
  4. Study completion24 Oct 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
Cohort
Time perspective
Prospective
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01488162
Sponsor's protocol ID
ML25664
Status last verified
Mar 2017
First submitted
4 Nov 2011
Last updated
22 Mar 2017
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 84 sites in France.

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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in France. 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?

Chemotherapy regimens associated with MabThera/Rituxan in management of relapse/refractory CLL: Percentage of patients receiving purine analogues/bendamustine/alkylating agents/other chemotherapy (time frame: 2 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 NCT01488162.

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 22 Mar 2017.

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