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Lymphocytic Leukemia, ChronicNCT01178086

A Study on Rituximab (MabThera) in Participants With Chronic Lymphocytic Leukemia (CLL)

An observational study of Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 1 site in Germany.

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 observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL. 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
Type of treatment
Injection or infusion
How many people
681 participants
Where
1 siteGermany
Study dates
22 Feb 2010to 30 Jun 2015
Phase
Observational
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

Study population: Participants with CLL on chemotherapy receiving rituximab

Who may be able to join

  • CLL requiring treatment
  • Participants receiving a chemotherapy in combination with rituximab (decision taken by doctor prior to and independent from inclusion in this non-interventional study)
  • After this trial started, an amendment to the study protocol was introduced, adding a further inclusion criterion: Comorbidities according to cumulative illness rating scale (CIRS) score greater than (>) 6 and/or creatinine clearance less than (<) 70 milliliters per minute (mL/min)

Who cannot join

  • Participants with contraindication to rituximab treatment

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

    Frechen, 50226

Other trials in Germany

About this study

Official title: Rituximab in the Treatment of Chronic Lymphocytic Leukemia, "CLL NIS"

This observational study will assess the therapeutic efficiency, treatment schedules, handling procedures, and the safety profile of rituximab in routine care in participants with CLL.

Being tested
Rituximab
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

    Also called MabThera

    Rituximab IV

Study groups in NCT01178086
Study groupRoleWhat they receive
Participants With CLLParticipants with CLL who are being treated with intravenous (IV) rituximab in combination with chemotherapy, will be observed for 24 months including 6-month treatment period.
Receives: Drug: Rituximab

What is being measured

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

  1. Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate

    PFS was defined as the time from initiation of treatment with rituximab in combination with chemotherapy to disease progression or death due to any cause, whichever occurred first. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (>/=) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes. Participants without disease progression or death at the time of analysis were censored at the last date of tumor evaluation in terms of PFS.

    Measured: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

  2. Percentage of Participants Without Progression or Death

    Disease progression was defined as the occurrence of at least one of the following: >/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes.

    Measured: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

Secondary outcomes (8)

  1. Percentage of Participants With Progression and Death

    Percentage of participants with an event (progression or death) was reported. Disease progression was defined as the occurrence of at least one of the following: >/=50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or >/=50% increase in the number of circulating lymphocytes.

    Measured: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

  2. Percentage of Participants Who Received Each Treatment During the Course of Study

    The chemotherapeutic regimen administereted during the course of study were: Rituximab-Bendamustine (R-Benda), Rituximab-Fludarabine-Cyclophosphamide (R-FC), Rituximab-Clorambucil (R-Clb), R-Other and Rituximab mono.

    Measured: Baseline, Cycle 1, 2, 3, 4, 5, 6, 7, 8, last Cycle (Cycle 18) (each cycle=1 month)

  3. Mean Body Weight

    Measured: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

  4. Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

    ECOG performance status was measured on a 4 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours.

    Measured: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

  5. Percentage of Participants With Karnofsky Performance Status Index

    Performance status was reflected by the Karnofsky index. Karnofsky performance status index ranges from 0-100% with higher scores indicating better functional status. An index between 90% and 100% corresponds to ECOG grade 0, index between 70% and 80% corresponds to ECOG grade 1, index between 50% and 60% corresponds to ECOG grade 2, index 40% corresponds to ECOG grade 3. ECOG grade 0=Fully active, able to carry on all pre-disease activities without restriction; grade 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; grade 2=Ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; grade 3=Capable of only limited self-care, confined to bed/chair >50% of waking hours.

    Measured: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

  6. Percentage of Participants With General Symptoms

    General symptoms included fatigue, reduced performance, frequent infections, abdominal pain and exhaustion.

    Measured: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

  7. Percentage of Participants With B-Symptoms

    B-symptoms included fever, night sweats, weight loss.

    Measured: Baseline, last cycle (Cycle 18) (each cycle=1 month), last visit (follow-up) (24 months)

  8. Percentage of Participants With Best Overall Response (BOR)

    Response to treatment was assessed as per clinical routine. BOR included complete response(CR or CR with incomplete hematopoietic regeneration),partial response(PR or nodular PR),stable disease(SD),progressive disease(PD). CR:hemoglobin>/=11 grams/deciliter(g/dL), lymphocytes<4000 cells/cubic millimeter(cells/mm^3), neutrophils>5000 cells/mm^3,platelets>100,000 cells/mm^3,bone marrow biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, performance status of 0. PR:>50% decrease in size of enlarged lymph nodes, hepatomegaly, splenomegaly, with peripheral counts meeting same criteria as CR or >/=50% improvement from pre-treatment values.PD:occurrence of at least one of following: >/=50% increase in longest diameter of at least 2 enlarged lymph nodes, increase in spleen and liver size by at least 2 cm from Baseline, or >/=50% increase in number of circulating lymphocytes. Participants without CR/PR or PD were considered having SD.

    Measured: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)

Timeline

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

  1. First posted9 Aug 2010 (estimated)
  2. Study start22 Feb 2010
  3. Primary completion30 Jun 2015
  4. Study completion30 Jun 2015

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
681 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01178086
Sponsor's protocol ID
ML22610
Status last verified
Dec 2017
First submitted
6 Aug 2010
Last updated
5 Oct 2018

Publications

  • Reiser M, Dorfel S, Hensel M, Hoesl M, Jordan WO, Koenigsmann M, Meyer D, Reichert D, Schwarzer A, Marquardt M, Kellershohn K, Jentsch-Ullrich K. Rituximab in combination with chemotherapy for the treatment of chronic lymphocytic leukaemia in clinical practice. Eur J Haematol. 2018 May;100(5):455-464. doi: 10.1111/ejh.13040. Epub 2018 Mar 22.

    PubMed 29393986

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 1 site in Germany.

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 1 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 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Yes. Results are posted in the registry (first posted 5 Oct 2018). 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?

Progression-Free Survival (PFS) as Assessed Using Kaplan-Meier Estimate (time frame: From initiation of treatment up to disease progression or death due to any cause, whichever occurred first (assessed up to 24 months)). The study lists 2 primary outcomes in all. 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 NCT01178086, 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 5 Oct 2018.

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