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Chronic Lymphocytic LeukemiaPhase 2LLCRlowdozNCT01521689

Tolerance and Efficacy of Subcutanous Low Doses Rituximab for CLL Consolidation Treatment

A Phase 2 study testing Rituximab in people with Chronic Lymphocytic Leukemia, run by Institut Paoli-Calmettes at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Chronic Lymphocytic Leukemia (CLL) is still an incurable disease. However recent advances have established correlation between the quality of the response (in particular achievement of negativity of minimal residual disease (MRD) and progression free and overall survival. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteFrance
Study dates
Dec 2011to Jun 2015
Phase
Phase 2
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

  • CLL (Matutes 4 or 5) in CR after induction treatment with negative MRD or PR
  • age>18
  • performance status<=2
  • signed informed consent

Who cannot join

  • cytopenia
  • other malignant affection
  • HIV or HBV positive
  • steroids treatment
  • richter syndrome
  • pregnant or breastfeeding women

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Paoli Calmettes

    Marseille, 13009

Other trials in France

About this study

Official title: Phase II Study of Tolerance and Efficacy of Subcutanous Low Doses Rituximab Given as Consolidation Treatment to Chronic Lymphocytic Leukaemia (CLL) Patients Responding to Induction Therapy

Chronic Lymphocytic Leukemia (CLL) is still an incurable disease. However recent advances have established correlation between the quality of the response (in particular achievement of negativity of minimal residual disease (MRD) and progression free and overall survival. That is why MRD negative complete remission (CR) is the current goal in CLL treatment.

The association of Rituximab fludarabine cyclophosphamide leads to the best response rate with 52 to 72% CR in "medically" fit untreated CLL patients. MRD results in this setting are still preliminary and around 50%. However many other situations (unfit, elderly, relapse, haematological toxicity leading to early interruption of treatment…) are associated with much lower response rate that would be improved by consolidation treatment.

Read more

Monoclonal antibodies are the treatment of choice for consolidation because of sparing marrow and targeting CLL cells. Alemtuzumab has been used for this purpose and results confirm improvement of CR and MRD negative responses but alemtuzumab induced immunodeficiency lead to unacceptable infectious complications. Rituximab monotherapy induces low response rate at standard dose regimen. This is at least partially due to shaving of CD20, mechanism by which CD20 is lost from the leukemic cells but these cells are not cleared. Using low doses of rituximab reduced shaving and allowed CLL cells clearance by the mononuclear phagocytic system. Such low doses of rituximab can be administered subcutaneously.

The investigators then propose subcutaneous low dose rituximab in consolidation to CLL patients responding after induction but having not achieved MRD negative CR.

Read the detailed description

Objective(s) of the clinical study

Main objective:

  • To improve the minimal residual disease (MRD) negative complete response (CR) rate after consolidation using subcutaneous low dose of rituximab

Secondary objectives:

  • Progression free survival, treatment free survival, overall survival,
  • MRD follow-up,
  • Safety
  • Medico-economic study
  • Quality of life study
  • Immune functions study (ancillary study)

Main assessment criteria:

MRD negative CR rate, established by peripheral blood 4colour flow cytometry according to international consensus on CLL MRD study, at the end of the consolidation treatment.

Experimental plan:

Inclusion of patients after the evaluation of response to induction treatment according to NCI-ICLLWG criteria and MRD analysis (2 to 3 months after induction completion): patients having not achieved MRD negative CR.

Consolidation treatment by subcutaneous rituximab given at 20 mg/m²/d thrice weekly during 12 weeks.

Evaluation of the response 3 months after completion of the consolidation treatment.

Subjects number: 35 patients will be needed to accept the hypothesis of an augmentation of CR with negative MRD >=40%, excluding the hypothesis that this rate is < 20%. This ensure us an alpha risk at 5% with a 80% power, taking into account that non evaluable patients will be < 5%.

Brief description of the ancillary study:

Immune functions study before and after consolidation treatment by rituximab

Being tested
Rituximab
Keywords
MRD negative CR
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

    Low doses of sub cutaneaous rituximab

Study groups in NCT01521689
Study groupRoleWhat they receive
RituximabExperimentalConsolidation treatment with sub cutaneaous low doses of Rituximab
Receives: Drug: Rituximab

What is being measured

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

  1. Residual disease

    • minimal residual disease (MRD) negative complete response (CR) rate after consolidation using subcutaneous low dose of rituximab, from randomisation up to 3 month after the end of treatment

    Measured: up to 3 month after the end of treatment

Secondary outcomes (6)

  1. overall survival

    time between inclusion and death

    Measured: From date of inclusion until date of death, assessed up to 10 years

  2. Adverse events

    Number and description of adverse events recorded according to the CTC-AE V4

    Measured: up to 3 months

  3. -Quality of life

    -Quality of life study by QLQ-C30

    Measured: up to 3 months after the end of treatment

  4. Immune functions

    NK, monocytes, CD8, and CD 20 expression on leucemic cells or B cells

    Measured: up to 3 months after the end of treatment

  5. - Progression free survival

    Time between inclusion and progression

    Measured: up to time of progression assessed up to 10 years

  6. treatment free survival

    time between end of treatment and restarting a new treatement

    Measured: up to time of new treatment assessed up to 10 years

Timeline

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

  1. First posted31 Jan 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionJun 2015 (estimated)
  4. Study completionJun 2015 (estimated)

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
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01521689
Sponsor's protocol ID
LLCR lowdoz / IPC 2009-004
Acronym
LLCRlowdoz
Status last verified
Mar 2015
First submitted
22 Dec 2011
Last updated
20 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab in people with Chronic Lymphocytic Leukemia, run by Institut Paoli-Calmettes at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 20 Mar 2015. 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 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 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?

Results are not available in the source record.

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?

Residual disease (time frame: up to 3 month after the end of treatment). 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 NCT01521689.

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 20 Mar 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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