Autoimmune Cytopenia Associated With Chronic Lymphocytic LeukemiaCABRINCT03469895
Autoimmune Cytopenia and BcR Inhibitors
An observational study of Autoimmune Cytopenia Associated With Chronic Lymphocytic Leukemia, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated with Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Cytopenia Associated With Chronic Lymphocytic Leukemia
- What is being tested?
- ibrutinib ou idelalisib
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2017to Jul 2018
- 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
- Adult, Older adult
Study population: Patients with CLL and active autoimmune cytopenia treated with ibrutinib or idelalisib for autoimmune cytopenia.
Who may be able to join
- Patient with CLL
- Active autoimmune cytopenia
- Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia.
Who cannot join
- Other lymphoid hemopathy B
- Absence of documentation of the autoimmunity of cytopenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated With Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)
Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated with Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)
Read the detailed description
The investigators of the study propose a card of data collection, validated by the scientific council of the group FILO.
The data to be collected are entered on an e-CRF made available to the investigators on a secure site.
The main data collected are as follows
- anonymized demographic data
- Clinical and Biological Data of CLL at Diagnosis
- Previous treatments of LLC and CAI
- clinical and laboratory data at the time of initiation of BCRi treatment
- response to treatment with BCRi
- tolerance to BCRi treatment
- Progression under treatment with BCRi
- Recent news
- Being tested
- ibrutinib ou idelalisib
- Keywords
- Chronic Lymphocytic Leukemia, Autoimmune Cytopenias, BCR inhibitors
- 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.
ibrutinib ou idelalisibDrug
treatment by ibrutinib or idelalisib for autoimmune cytopenia
| Study group | Role | What they receive |
|---|---|---|
| active CLL treated with ibrutinib or idelalisib for CAI | Patient with CLL Active autoimmune cytopenia Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia.
The progressive nature of contemporary CAI LLC is not a criterion of exclusion. Receives: Drug: ibrutinib ou idelalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of B-cell receptor inhibitors on autoimmune cytopenia (AIC)
Regarding autoimmune cytopenias, the responses to treatments were defined as such:
Complete answer
- hemoglobin level> 120 g/l without transfusion
- AND platelet count> 100 G/l
- AND reticulocytes <100 G/l
- AND normal LDH level Partial answer
- hemoglobin <120 g/l but with a gain of 2 g/l, without transfusion
- OR hemoglobin> 120 g/l with reticulocytes> 100 G/l and or high LDH
- OR hemoglobin> 120 g/l with reticulocytes and / or LDH levels not available
- AND OR platelet count between 50 and 100 G/l
Measured: 1 year
Secondary outcomes (7)
Efficacy of B-cell receptor inhibitors on the Chronic lymphocytic leukemia (CLL)
Regarding CLL, the responses were defined according to the IWCLL 2008 criteria. Due to the absence of a medullary assessment biopsy, patients presenting the complete clinical and biological response criteria will be considered in a complete clinical response.
Measured: 1 year
Progression Free Survival (PFS) of the autoimmune cytopenia
Progression Free Survival (PFS) of the autoimmune cytopenia
Measured: 1 year
PFS of the Chronic lymphocytic leukemia
PFS of the Chronic lymphocytic leukemia
Measured: 1 year
Event Free Survival (EFS)
Event Free Survival (EFS)
Measured: 1 year
Time to next treatment (TTNT)
Time to next treatment (TTNT)
Measured: 1 year
Toxicity profile
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 year
Overall survival
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start21 Jul 2017
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Cytopenia Associated With Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Reims
- Responsible party
- Sponsor
- Investigators
- Thérèse Aurran-Schleinitz, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469895
- Sponsor's protocol ID
- CABRI-IPC 2017-025
- Acronym
- CABRI
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hodgson K, Ferrer G, Montserrat E, Moreno C. Chronic lymphocytic leukemia and autoimmunity: a systematic review. Haematologica. 2011 May;96(5):752-61. doi: 10.3324/haematol.2010.036152. Epub 2011 Jan 17.
PubMed 21242190Dierickx D, Kentos A, Delannoy A. The role of rituximab in adults with warm antibody autoimmune hemolytic anemia. Blood. 2015 May 21;125(21):3223-9. doi: 10.1182/blood-2015-01-588392. Epub 2015 Mar 31.
PubMed 25827833D'Arena G, Laurenti L, Capalbo S, D'Arco AM, De Filippi R, Marcacci G, Di Renzo N, Storti S, Califano C, Vigliotti ML, Tarnani M, Ferrara F, Pinto A. Rituximab therapy for chronic lymphocytic leukemia-associated autoimmune hemolytic anemia. Am J Hematol. 2006 Aug;81(8):598-602. doi: 10.1002/ajh.20665.
PubMed 16823816Reynaud Q, Durieu I, Dutertre M, Ledochowski S, Durupt S, Michallet AS, Vital-Durand D, Lega JC. Efficacy and safety of rituximab in auto-immune hemolytic anemia: A meta-analysis of 21 studies. Autoimmun Rev. 2015 Apr;14(4):304-13. doi: 10.1016/j.autrev.2014.11.014. Epub 2014 Dec 9.
PubMed 25497766Kaufman M, Limaye SA, Driscoll N, Johnson C, Caramanica A, Lebowicz Y, Patel D, Kohn N, Rai K. A combination of rituximab, cyclophosphamide and dexamethasone effectively treats immune cytopenias of chronic lymphocytic leukemia. Leuk Lymphoma. 2009 Jun;50(6):892-9. doi: 10.1080/10428190902887563.
PubMed 19391041Rossignol J, Michallet AS, Oberic L, Picard M, Garon A, Willekens C, Dulery R, Leleu X, Cazin B, Ysebaert L. Rituximab-cyclophosphamide-dexamethasone combination in the management of autoimmune cytopenias associated with chronic lymphocytic leukemia. Leukemia. 2011 Mar;25(3):473-8. doi: 10.1038/leu.2010.278. Epub 2010 Dec 3.
PubMed 21127498Quinquenel A, Willekens C, Dupuis J, Royer B, Ysebaert L, De Guibert S, Michallet AS, Feugier P, Guieze R, Levy V, Delmer A. Bendamustine and rituximab combination in the management of chronic lymphocytic leukemia-associated autoimmune hemolytic anemia: a multicentric retrospective study of the French CLL intergroup (GCFLLC/MW and GOELAMS). Am J Hematol. 2015 Mar;90(3):204-7. doi: 10.1002/ajh.23909. Epub 2015 Jan 16.
PubMed 25428829Maura F, Visco C, Falisi E, Reda G, Fabris S, Agnelli L, Tuana G, Lionetti M, Guercini N, Novella E, Nichele I, Montaldi A, Autore F, Gregorini A, Barcellini W, Callea V, Mauro FR, Laurenti L, Foa R, Neri A, Rodeghiero F, Cortelezzi A. B-cell receptor configuration and adverse cytogenetics are associated with autoimmune hemolytic anemia in chronic lymphocytic leukemia. Am J Hematol. 2013 Jan;88(1):32-6. doi: 10.1002/ajh.23342. Epub 2012 Oct 31.
PubMed 23115077Byrd JC, Furman RR, Coutre SE, Burger JA, Blum KA, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Shaw Y, Bilotti E, Zhou C, James DF, O'Brien S. Three-year follow-up of treatment-naive and previously treated patients with CLL and SLL receiving single-agent ibrutinib. Blood. 2015 Apr 16;125(16):2497-506. doi: 10.1182/blood-2014-10-606038. Epub 2015 Feb 19.
PubMed 25700432Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.
PubMed 24881631Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, O'Dwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ; RESONATE-2 Investigators. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015 Dec 17;373(25):2425-37. doi: 10.1056/NEJMoa1509388. Epub 2015 Dec 6.
PubMed 26639149St Bernard R, Hsia CC. Safe utilization of ibrutinib with or without steroids in chronic lymphocytic leukemia patients with autoimmune hemolytic anemia. Ann Hematol. 2015 Dec;94(12):2077-9. doi: 10.1007/s00277-015-2487-8. Epub 2015 Sep 3. No abstract available.
PubMed 26334319Manda S, Dunbar N, Marx-Wood CR, Danilov AV. Ibrutinib is an effective treatment of autoimmune haemolytic anaemia in chronic lymphocytic leukaemia. Br J Haematol. 2015 Sep;170(5):734-6. doi: 10.1111/bjh.13328. Epub 2015 Feb 25. No abstract available.
PubMed 25716177Rogers KA, Ruppert AS, Bingman A, Andritsos LA, Awan FT, Blum KA, Flynn JM, Jaglowski SM, Lozanski G, Maddocks KJ, Byrd JC, Woyach JA, Jones JA. Incidence and description of autoimmune cytopenias during treatment with ibrutinib for chronic lymphocytic leukemia. Leukemia. 2016 Feb;30(2):346-50. doi: 10.1038/leu.2015.273. Epub 2015 Oct 7.
PubMed 26442611Vitale C, Ahn IE, Sivina M, Ferrajoli A, Wierda WG, Estrov Z, Konoplev SN, Jain N, O'Brien S, Farooqui M, Keating MJ, Wiestner A, Burger JA. Autoimmune cytopenias in patients with chronic lymphocytic leukemia treated with ibrutinib. Haematologica. 2016 Jun;101(6):e254-8. doi: 10.3324/haematol.2015.138289. Epub 2016 Mar 24. No abstract available.
PubMed 27013651
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated With Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)
- ClinicalTrials.gov ID
- NCT03469895
- Acronym / sponsor ID
- CABRI / CABRI-IPC 2017-025
- Keywords
- Chronic Lymphocytic Leukemia, Autoimmune Cytopenias, BCR inhibitors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- CHU de Reims
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 19 Mar 2018 (actual)
- 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.
Efficacy of BCR Inhibitors in the Treatment of Autoimmune Cytopenias Associated with Chronic Lymphocytic Leukemia (CLL): A Retrospective Analysis of the French Innovative Leukemia Organization (FILO)
Detailed description
The investigators of the study propose a card of data collection, validated by the scientific council of the group FILO.
The data to be collected are entered on an e-CRF made available to the investigators on a secure site.
The main data collected are as follows
- anonymized demographic data
- Clinical and Biological Data of CLL at Diagnosis
- Previous treatments of LLC and CAI
- clinical and laboratory data at the time of initiation of BCRi treatment
- response to treatment with BCRi
- tolerance to BCRi treatment
- Progression under treatment with BCRi
- Recent news
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active CLL treated with ibrutinib or idelalisib for CAI | – | Drug: ibrutinib ou idelalisibPatient with CLL Active autoimmune cytopenia Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia. The progressive nature of contemporary CAI LLC is not a criterion of exclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with CLL and active autoimmune cytopenia treated with ibrutinib or idelalisib for autoimmune cytopenia.
Key inclusion criteria (3 listed)
- Patient with CLL
- Active autoimmune cytopenia
- Initiation of a treatment with ibrutinib or idelalisib for autoimmune cytopenia.
Key exclusion criteria (2 listed)
- Other lymphoid hemopathy B
- Absence of documentation of the autoimmunity of cytopenia
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 |
|---|---|---|
| ibrutinib ou idelalisibtreatment by ibrutinib or idelalisib for autoimmune cytopenia | Drug | active CLL treated with ibrutinib or idelalisib for CAI |
Primary outcome
Efficacy of B-cell receptor inhibitors on autoimmune cytopenia (AIC)
Time frame: 1 year
Regarding autoimmune cytopenias, the responses to treatments were defined as such: Complete answer * hemoglobin level> 120 g/l without transfusion * AND platelet count> 100 G/l * AND reticulocytes <100 G/l * AND normal LDH level Partial answer * hemoglobin <120 g/l but with a gain of 2 g/l, without transfusion * OR hemoglobin> 120 g/l with reticulocytes> 100 G/l and or high LDH * OR hemoglobin> 120 g/l with reticulocytes and / or LDH levels not available * AND OR platelet count between 50 and 100 G/l
7 secondary outcomes
Efficacy of B-cell receptor inhibitors on the Chronic lymphocytic leukemia (CLL)
Time frame: 1 year
Progression Free Survival (PFS) of the autoimmune cytopenia
Time frame: 1 year
PFS of the Chronic lymphocytic leukemia
Time frame: 1 year
Event Free Survival (EFS)
Time frame: 1 year
Time to next treatment (TTNT)
Time frame: 1 year
Toxicity profile
Time frame: 1 year
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Background: PubMed 21242190Hodgson K, Ferrer G, Montserrat E, Moreno C. Chronic lymphocytic leukemia and autoimmunity: a systematic review. Haematologica. 2011 May;96(5):752-61. doi: 10.3324/haematol.2010.036152. Epub 2011 Jan 17.
- Background: PubMed 25827833Dierickx D, Kentos A, Delannoy A. The role of rituximab in adults with warm antibody autoimmune hemolytic anemia. Blood. 2015 May 21;125(21):3223-9. doi: 10.1182/blood-2015-01-588392. Epub 2015 Mar 31.
- Background: PubMed 16823816D'Arena G, Laurenti L, Capalbo S, D'Arco AM, De Filippi R, Marcacci G, Di Renzo N, Storti S, Califano C, Vigliotti ML, Tarnani M, Ferrara F, Pinto A. Rituximab therapy for chronic lymphocytic leukemia-associated autoimmune hemolytic anemia. Am J Hematol. 2006 Aug;81(8):598-602. doi: 10.1002/ajh.20665.
- Background: PubMed 25497766Reynaud Q, Durieu I, Dutertre M, Ledochowski S, Durupt S, Michallet AS, Vital-Durand D, Lega JC. Efficacy and safety of rituximab in auto-immune hemolytic anemia: A meta-analysis of 21 studies. Autoimmun Rev. 2015 Apr;14(4):304-13. doi: 10.1016/j.autrev.2014.11.014. Epub 2014 Dec 9.
- Background: PubMed 19391041Kaufman M, Limaye SA, Driscoll N, Johnson C, Caramanica A, Lebowicz Y, Patel D, Kohn N, Rai K. A combination of rituximab, cyclophosphamide and dexamethasone effectively treats immune cytopenias of chronic lymphocytic leukemia. Leuk Lymphoma. 2009 Jun;50(6):892-9. doi: 10.1080/10428190902887563.
- Background: PubMed 21127498Rossignol J, Michallet AS, Oberic L, Picard M, Garon A, Willekens C, Dulery R, Leleu X, Cazin B, Ysebaert L. Rituximab-cyclophosphamide-dexamethasone combination in the management of autoimmune cytopenias associated with chronic lymphocytic leukemia. Leukemia. 2011 Mar;25(3):473-8. doi: 10.1038/leu.2010.278. Epub 2010 Dec 3.
- Background: PubMed 25428829Quinquenel A, Willekens C, Dupuis J, Royer B, Ysebaert L, De Guibert S, Michallet AS, Feugier P, Guieze R, Levy V, Delmer A. Bendamustine and rituximab combination in the management of chronic lymphocytic leukemia-associated autoimmune hemolytic anemia: a multicentric retrospective study of the French CLL intergroup (GCFLLC/MW and GOELAMS). Am J Hematol. 2015 Mar;90(3):204-7. doi: 10.1002/ajh.23909. Epub 2015 Jan 16.
- Background: PubMed 23115077Maura F, Visco C, Falisi E, Reda G, Fabris S, Agnelli L, Tuana G, Lionetti M, Guercini N, Novella E, Nichele I, Montaldi A, Autore F, Gregorini A, Barcellini W, Callea V, Mauro FR, Laurenti L, Foa R, Neri A, Rodeghiero F, Cortelezzi A. B-cell receptor configuration and adverse cytogenetics are associated with autoimmune hemolytic anemia in chronic lymphocytic leukemia. Am J Hematol. 2013 Jan;88(1):32-6. doi: 10.1002/ajh.23342. Epub 2012 Oct 31.
- Background: PubMed 25700432Byrd JC, Furman RR, Coutre SE, Burger JA, Blum KA, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Shaw Y, Bilotti E, Zhou C, James DF, O'Brien S. Three-year follow-up of treatment-naive and previously treated patients with CLL and SLL receiving single-agent ibrutinib. Blood. 2015 Apr 16;125(16):2497-506. doi: 10.1182/blood-2014-10-606038. Epub 2015 Feb 19.
- Background: PubMed 24881631Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.
- Background: PubMed 26639149Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, O'Dwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ; RESONATE-2 Investigators. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med. 2015 Dec 17;373(25):2425-37. doi: 10.1056/NEJMoa1509388. Epub 2015 Dec 6.
- Background: PubMed 26334319St Bernard R, Hsia CC. Safe utilization of ibrutinib with or without steroids in chronic lymphocytic leukemia patients with autoimmune hemolytic anemia. Ann Hematol. 2015 Dec;94(12):2077-9. doi: 10.1007/s00277-015-2487-8. Epub 2015 Sep 3. No abstract available.
- Individual participant dataSharing planned: No
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.
Thérèse Aurran-Schleinitz principal investigator
Institut Paoli-Calmettes
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 Autoimmune Cytopenia Associated 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 3 inclusion and 2 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 19 Mar 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 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?
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?
Efficacy of B-cell receptor inhibitors on autoimmune cytopenia (AIC) (time frame: 1 year). 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 NCT03469895, which also lists 16 linked publications.
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 19 Mar 2018.