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Chronic Lymphocytic LeukemiaPhase 3NCT01118234

Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)

A Phase 3 study testing Rituximab in people with Chronic Lymphocytic Leukemia, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 22 sites in 3 countries.

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

The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
22 sitesin 3 countries
Study dates
Dec 2009to Jul 2019
Phase
Phase 3
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

Who may be able to join

  • B-CLL
  • Age >18
  • ECOG performance status 0-2
  • Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
  • Patient must be in complete remission or partial remission after an induction treatment containing rituximab
  • ANC (absolute neutrophil count) > 1,0 x 10e9 /L
Show all 9Show fewer
  • Life expectancy > 6 months
  • Patient´s written informed consent
  • Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter

Who cannot join

  • Active uncontrolled bacterial, viral or fungal infection
  • Significantly reduced organ functions and bone marrow dysfunction not due to CLL
  • creatinine clearance of below 30mL/min
  • Patients with a history of other malignancies within 2 years prior to study entry
  • Patients with a history of severe cardiac disease
  • Other known comorbidity with the potential to dominate survival
Show all 11Show fewer
  • Transformation to aggressive B-cell malignancy
  • Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs
  • Medical condition requiring prolonged (> 1 month) use of oral corticosteroids
  • Pregnant or breast feeding women
  • Any coexisting medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

Trial locations and contacts

22 sites in 3 countries.

22 sites in 3 countries

Austria11 sites

  • LKH Feldkirch, Interne E

    Feldkirch, Vorarlberg, 6807

  • A.ö. Bezirkskrankenhaus Hall in Tirol, Innere Medizin / Hämato - Onkologie

    Hall in Tirol, Tyrol, 6060

  • Universitätsklinik Innsbruck, Innere MEdizin IV / Hämato-Onkologie

    Innsbruck, Tyrol, 6020

  • Landesklinikum Krems, Hämato-onkologisches Service

    Krems, Lower Austria, 3500

  • A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie

    Kufstein, Tyrol, 6330

  • AKH Linz, Department für Innere Medizin 3

    Linz, Upper Austria, 4021

  • Universitätsklinik der PMU Salzburg, Univ-Klinik für Innere Medizin

    Salzburg, 5020

  • Landeskrankenhaus Steyr, Innere Medizin, Hämatologie, Onkologie

    Steyr, Upper Austria, 4400

  • AKH Wien, Klinische Abteilung für Hämatologie und Hämostaseologie

    Vienna, 1090

  • Hanusch Krankenhaus, 3. Med. Abtlg.

    Vienna, 1140

  • Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV

    Wels, Upper Austria, 4600

Other trials in Austria

Slovakia6 sites

  • F.D. Rossevelt hospital

    Banská Bystrica, 97517

  • Narodny onkologicky ustav

    Bratislava, 83310

  • FNsP sv. Cyrila a Metoda

    Bratislava, 85107

  • FNsP L.Pasteura

    Košice, 04190

  • Martinska fakultna nemocnica

    Martin, 03659

  • FNsP J.A. Reimana

    Prešov, 08181

Other trials in Slovakia

Czechia5 sites

  • FN Brno

    Brno, 62588

  • FN Hradec Kralove

    Hradec Králové, 500 05

  • FN Olomouc

    Olomouc

  • FN Kralovske Vinohrady

    Prague, 10034

  • VFN Praha 2

    Prague, 12808

Other trials in Czechia

About this study

Official title: International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia

The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.

Being tested
Rituximab
Keywords
CLL, Rituximab, Maintenance
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.

  • RituximabDrug

    Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation

Study groups in NCT01118234
Study groupRoleWhat they receive
RituximabExperimentalTreatment with Rituximab 375 mg/m² every 3 months for 24 months
Receives: Drug: Rituximab
ObservationNo interventionObservation for 24 months

What is being measured

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

  1. progression free survival

    Clinical PFS is defined as the period from randomization until disease progression according to the NCI criteria or death due to the underlying disease.

    Measured: 48 months

Secondary outcomes (10)

  1. MRD (minimal residual disease) progression free survival

    Minimal residual disease progression-free survival is defined as the period from randomization until increase of MRD levels in peripheral blood above 10-3 or, if above 10-3 before, increase of one common logarithm.

    Measured: 48 months

  2. conversion rate to MRD negative

    Measured: 48 months

  3. median MRD levels

    Measured: 48 months

  4. conversation rate to CR

    Measured: 48 months

  5. effect of MRD levels on clinical PFS and OS

    Measured: 48 months

  6. event free survival

    Measured: 48 months

  7. time to next treatment

    Measured: 48 months

  8. overall survival

    Measured: 48 months

  9. Safety of Rituximab maintenance treatment in patients with CLL

    All grades of infections and G3/4 other clinical adverse events will be documented using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0

    Measured: 48 months

  10. benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q), IgVH mutation status, ZAP 70 and CD38 expression

    Measured: 48 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 May 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionFeb 2018
  4. Study completionJul 2019

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01118234
Sponsor's protocol ID
Mabtenance
Status last verified
Jan 2020
First submitted
3 May 2010
Last updated
9 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • Greil R, Obrtlikova P, Smolej L, Kozak T, Steurer M, Andel J, Burgstaller S, Mikuskova E, Gercheva L, Nosslinger T, Papajik T, Ladicka M, Girschikofsky M, Hrubisko M, Jager U, Fridrik M, Pecherstorfer M, Kralikova E, Burcoveanu C, Spasov E, Petzer A, Mihaylov G, Raynov J, Oexle H, Zabernigg A, Flochova E, Palasthy S, Stehlikova O, Doubek M, Altenhofer P, Pleyer L, Melchardt T, Klingler A, Mayer J, Egle A. Rituximab maintenance versus observation alone in patients with chronic lymphocytic leukaemia who respond to first-line or second-line rituximab-containing chemoimmunotherapy: final results of the AGMT CLL-8a Mabtenance randomised trial. Lancet Haematol. 2016 Jul;3(7):e317-29. doi: 10.1016/S2352-3026(16)30045-X. Epub 2016 Jun 16.

    PubMed 27374465

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab in people with Chronic Lymphocytic Leukemia, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 22 sites in 3 countries.

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 9 inclusion and 11 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Austria, Slovakia, Czechia. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

progression free survival (time frame: 48 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 NCT01118234, which also lists 1 linked publication.

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 9 Jan 2020.

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