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Lymphocytic Leukemia, ChronicPhase 2NCT02013817

CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy

A Phase 2 study testing rituximab [MabThera/Rituxan], fludarabine and cyclophosphamide in people with Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 8 sites in Austria.

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 study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years. 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?
rituximab [MabThera/Rituxan], fludarabine and cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
8 sitesAustria
Study dates
11 Oct 2005to 24 Sep 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adult patients, >/= 18 years of age
  • B-cell CLL
  • No previous chemotherapy, radiotherapy, or immunotherapy

Who cannot join

  • Reduced organ function, or bone marrow dysfunction not due to CLL
  • Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer
  • Patients with a history of severe cardiac disease.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Austria8 sites

  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

    Innsbruck, 6020

  • LKH Hochsteiermark; Abt. für Innere Medizin

    Leoben, 8700

  • Kh Der Barmherzigen Schwestern; Interne I X

    Linz, 4010

  • A.Ö. Krankenhaus Der Elisabethinen Linz; I. Interne Abt.

    Linz, 4020

  • Kepler Universitätskliniken GmbH - Med Campus III; I. Medizinische Abteilung

    Linz, 4020

  • Landeskrankenhaus Rankweil; Interne E

    Rankweil, 6830

  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

    Salzburg, 5020

  • Klinikum Kreuzschwestern Wels; Iii. Interne Abt.

    Wels, 4600

Other trials in Austria

About this study

Official title: CHAIROS - Effect of Early Brief Intensification by Chemoimmunotherapy With FCR Followed by FR and Rituximab Maintenance on Clinical Response in Chemo-naïve Patients With B-CLL

This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.

Being tested
rituximab [MabThera/Rituxan], fludarabine, cyclophosphamide
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.

  • rituximab [MabThera/Rituxan]Drug

    Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8

  • fludarabineDrug

    Every 4 weeks, 6 cycles

  • cyclophosphamideDrug

    Every 4 weeks, 3 cycles

Study groups in NCT02013817
Study groupRoleWhat they receive
MabThera/RituxanExperimentalNot described
Receives: Drug: rituximab [MabThera/Rituxan]; Drug: fludarabine; Drug: cyclophosphamide

What is being measured

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

  1. Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)

    Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (>)1500 per microliter (/µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC.

    Measured: Weeks 1, 5, 9, 12, 13, 17, 21 and 24

Secondary outcomes (5)

  1. Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)

    Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, partial remission (PR), partial remission with toxicity associated (PRTox), progressive disease (PD), and stable disease (SD) were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). Last observation carried forward (LOCF) method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.

    Measured: Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)

  2. Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)

    Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, PR, PRTox, PD, and SD were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). LOCF method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.

    Measured: Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)

  3. Time to Next Treatment - Percentage of Participants With an Event

    Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.

    Measured: Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months

  4. Time to Next Treatment - Time to Event

    Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.

    Measured: Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months

  5. Percentage of Participants With Adverse Events (AEs)

    AEs were recorded from the date of first medication administration until 28 days after the last trial medication.

    Measured: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.

Timeline

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

  1. First posted17 Dec 2013 (estimated)
  2. Study start11 Oct 2005
  3. Primary completion24 Sep 2012
  4. Study completion24 Sep 2012

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02013817
Sponsor's protocol ID
ML18434
Status last verified
Jul 2017
First submitted
3 Dec 2013
Last updated
18 Aug 2017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab [MabThera/Rituxan], fludarabine and cyclophosphamide in people with Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 8 sites in Austria.

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 3 inclusion and 3 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 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Austria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With a Best Clinical Response of Clinical Remission (CR) (time frame: Weeks 1, 5, 9, 12, 13, 17, 21 and 24). 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 NCT02013817.

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 18 Aug 2017.

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