Hairy-cell LeukemiaRITUX-LEUKEMIANCT02883946
Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study
An observational study of Hairy-cell Leukemia, run by CHU de Reims at 1 site in France.
Trial summary
Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hairy-cell Leukemia
- What is being tested?
- Data collection
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Jun 2014
- Phase
- Observational
- 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
Study population: Patients with hairy-cell leukemia.
Who may be able to join
- patients with hairy-cell leukemia diagnosed between July 2002 and September 2012
- patients had received at least 3 subsequent injections of rituximab
- aged > 18 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients.
However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse.
Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.
Read the detailed description
Aims of the study were :
- to assess the overall efficacy of rituximab in a cohort of unselected patients with hairy-cell leukemia
- to identify factors associated to treatment response, to duration of treatment response and to patient survival in a cohort of unselected patients with hairy-cell leukemia
- Conditions
- Hairy-cell Leukemia
- Being tested
- Data collection
- Medical subject headings
- Leukemia, Hairy Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
| Study group | Role | What they receive |
|---|---|---|
| hairy-cell leukemia | Patients with hairy-cell leukemia. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete hematologic response to rituximab therapy
Complete hematologic response was defined as
- the recovery of normal blood counts (absolute neutrophil count ≥ 1.5x109/L, platelet count ≥ 100x109/L and hemoglobin level ≥ 120g/L for men and ≥ 110g/L for women)
- the absence of circulating cells of hairy-cell leukemia and clinical signs of hairy-cell leukemia
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJun 2012
- Primary completionFeb 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hairy-cell LeukemiaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883946
- Sponsor's protocol ID
- 2015Ao007
- Acronym
- RITUX-LEUKEMIA
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
Publications
Leclerc M, Suarez F, Noel MP, Vekhoff A, Troussard X, Claisse JF, Thieblemont C, Maloisel F, Beguin Y, Tamburini J, Barbe C, Delmer A. Rituximab therapy for hairy cell leukemia: a retrospective study of 41 cases. Ann Hematol. 2015 Jan;94(1):89-95. doi: 10.1007/s00277-014-2175-0. Epub 2014 Sep 7.
PubMed 25195120
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT02883946
- Acronym / sponsor ID
- RITUX-LEUKEMIA / 2015Ao007
- Conditions
- Hairy-cell Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients.
However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse.
Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.
Detailed description
Aims of the study were :
- to assess the overall efficacy of rituximab in a cohort of unselected patients with hairy-cell leukemia
- to identify factors associated to treatment response, to duration of treatment response and to patient survival in a cohort of unselected patients with hairy-cell leukemia
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hairy-cell leukemia | – | Other: Data collectionPatients with hairy-cell leukemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hairy-cell leukemia.
Key inclusion criteria (3 listed)
- patients with hairy-cell leukemia diagnosed between July 2002 and September 2012
- patients had received at least 3 subsequent injections of rituximab
- aged > 18 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection | Other | hairy-cell leukemia |
Primary outcome
Complete hematologic response to rituximab therapy
Time frame: Month 6
Complete hematologic response was defined as * the recovery of normal blood counts (absolute neutrophil count ≥ 1.5x109/L, platelet count ≥ 100x109/L and hemoglobin level ≥ 120g/L for men and ≥ 110g/L for women) * the absence of circulating cells of hairy-cell leukemia and clinical signs of hairy-cell leukemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Background: PubMed 25195120Leclerc M, Suarez F, Noel MP, Vekhoff A, Troussard X, Claisse JF, Thieblemont C, Maloisel F, Beguin Y, Tamburini J, Barbe C, Delmer A. Rituximab therapy for hairy cell leukemia: a retrospective study of 41 cases. Ann Hematol. 2015 Jan;94(1):89-95. doi: 10.1007/s00277-014-2175-0. Epub 2014 Sep 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hairy-cell Leukemia, run by CHU de Reims 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 3 inclusion and 0 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 Aug 2016. 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.
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?
Complete hematologic response to rituximab therapy (time frame: Month 6). 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 NCT02883946, 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 Aug 2016.