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Chronic Lymphocytic LeukemiaPhase 1NCT01098188

LFB-R603 Dose Finding in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia

A Phase 1 study testing LFB-R603 in people with Chronic Lymphocytic Leukemia, run by Laboratoire français de Fractionnement et de Biotechnologies at 9 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 study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
LFB-R603
Type of treatment
Injection or infusion
How many people
33 participants
Where
9 sitesFrance
Study dates
Nov 2008to Aug 2011
Phase
Phase 1
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Relapsed or refractory B-CLL after at least one prior course of therapy with fludarabine
  • Circulating lymphocytes expressing CD20
  • Peripheral blood lymphocyte count > 5,000/µL
  • ECOG performance status ≤ 2
  • Life expectancy ≥ 3 months
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  • Negative blood pregnancy test before inclusion for women of childbearing potential
  • Medically acceptable method of birth control throughout the study for women of childbearing potential
  • Being considered as reliable and capable of adhering to the protocol and compliant with study procedures
  • Covered by healthcare insurance

Who cannot join

  • Transformation of CLL into a high grade lymphoma
  • Allogeneic stem cell transplantation < 6 months before enrolment
  • Prior treatment with anti-CD20 monoclonal antibodies < 6 months before enrolment
  • Prior treatment with alemtuzumab < 2 months before enrolment
  • Treatment with any IMP or participation in a clinical study within 30 days prior to enrolment
  • Known severe anaphylactic or other hypersensitivity reactions secondary to a prior exposure to murine antibodies or to any component of LFB-R603
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  • Patient with prior treatment or concomitant medication that may interfere with the interpretation of the study data
  • Patient with a concomitant malignancy other than basal cell carcinoma of the skin, or in situ carcinoma of the cervix or the breast
  • Patient with serious non-malignant disease, active infection requiring systemic antibiotic, antifungal or antiviral drug or physical examination or laboratory abnormalities, that would compromise protocol objectives
  • Positive serology to HIV, HCV or presence of HBs Ag
  • Creatinine clearance, calculated according to Cockroft -Gault formula < 60 mL/min
  • ALT and /or AST level > 1.5 times the upper limit of normal
  • Pregnancy or breastfeeding

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • Clinique Victor Hugo

    Le Mans, 72000

  • Hôpital Hurriez

    Lille, 59037

  • Institut Paoli Calmettes

    Marseille, 13273

  • Hôpital Saint Eloi

    Montpellier, 34295

  • CH Lyon Sud

    Pierre-Bénite, 69495

  • Hôpital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: Open, Non-controlled, Multicentre, First-in-man Study Using Escalating Doses of LFB-R603 in Patients With Advanced Stage B-Chronic Lymphocytic Leukemia

This study is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of the anti-CD20 monoclonal antibody LFB-R603 in patients with relapsed or refractory B-cell chronic lymphocytic leukemia who have received at least one prior fludarabine-containing regimen.

Being tested
LFB-R603
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.

  • LFB-R603Drug

    Also called ublituximab

    intravenous administration, dose-escalation study

What is being measured

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

  1. Safety evaluated by adverse event(s) is the primary end-point of the study. Adverse events will be reported throughout the study period using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    Measured: on going

Timeline

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

  1. First posted2 Apr 2010 (estimated)
  2. Study startNov 2008
  3. Primary completionAug 2011
  4. Study completionAug 2011

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01098188
Sponsor's protocol ID
CD20-0703
Status last verified
Apr 2012
First submitted
31 Mar 2010
Last updated
30 Apr 2012
Results posted
No

Publications

  • de Romeuf C, Dutertre CA, Le Garff-Tavernier M, Fournier N, Gaucher C, Glacet A, Jorieux S, Bihoreau N, Behrens CK, Beliard R, Vieillard V, Cazin B, Bourel D, Prost JF, Teillaud JL, Merle-Beral H. Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16. Br J Haematol. 2008 Mar;140(6):635-43. doi: 10.1111/j.1365-2141.2007.06974.x.

    PubMed 18302712

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LFB-R603 in people with Chronic Lymphocytic Leukemia, run by Laboratoire français de Fractionnement et de Biotechnologies at 9 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 10 inclusion and 13 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 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety evaluated by adverse event(s) is the primary end-point of the study. Adverse events will be reported throughout the study period using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (time frame: on going). 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 NCT01098188, 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 30 Apr 2012.

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