CryptococcosisCRYPTONIBNCT07881055
Cryptococcosis Associated With Bruton Tyrosine Kinase Inhibitors
An observational study of Cryptococcosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to describe the clinical, biological, and radiographic characteristics at the time of cryptococcosis diagnosis, as well as the time interval between the initiation of BTK inhibitor therapy and the diagnosis of cryptococcosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptococcosis
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 treated for a cryptococcosis infection.
Who may be able to join
- Adult patient (≥18 years old)
- Patient with a diagnosis of microbiologically documented cryptococcosis (antigen, direct examination, culture) established between January 2013 and January 2024 by the clinicians treating the patient with a BTK inhibitor (BTKi)*.
- Cryptococcosis diagnoses will be validated by infectious disease expert (Prof. Fanny Lanternier, Dr. Olivier Paccoud) based on information provided by the clinicians treating the patient.
Who cannot join
- Patient objecting to the use of their data.
- Patient under legal guardianship or curatorship.
- Patient unable to provide free and informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Necker - Enfants Malades
Paris, Paris, 75015
Romain MANCHON, MD, 01 44 49 52 62 ext. +33
About this study
Official title: Clinical Features and Outcomes of Cryptococcosis Associated With Bruton Tyrosine Kinase Inhibitors: A Multicenter Retrospective Study
The purpose of this study is to describe the clinical, biological, and radiographic characteristics at the time of cryptococcosis diagnosis, as well as the time interval between the initiation of BTK inhibitor therapy and the diagnosis of cryptococcosis.
And also, the clinical course of each patient at 12 months in order to evaluate the susceptibility to cryptococcosis correlated with BTK inhibitor therapy.
Read the detailed description
Cryptococcosis is a fungal infection caused by a cosmopolitan encapsulated yeast known as Cryptococcus neoformans or Cryptococcus gattii. This invasive fungal disease exhibits cerebral, cutaneous, and pulmonary tropism; in cases involving the central nervous system, the mortality rate is 100% without treatment.
Although its pathogenicity in humans has been known since 1895, its incidence rose sharply with the emergence of HIV in the 1980s. Since the advent of combination antiretroviral therapies, a new population of immunocompromised individuals-specifically solid-organ transplant recipients and patient with haematological malignancy-constitutes the at-risk group.
Ibrutinib is a targeted therapy that inhibits Bruton's tyrosine kinase (BTK)-an enzyme involved in B-cell survival, activation, proliferation, and tumorigenesis. Having demonstrated efficacy in chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenström's macroglobulinemia, it has been widely used since 2016, either as monotherapy or in combination with anti-CD20 antibodies or venetoclax. Since the introduction of ibrutinib, other BTK inhibitors (BTKi) have been developed with indications overlapping those of ibrutinib.
The side effects of ibrutinib are diverse, including diarrhea, cytopenias, cardiac rhythm disorders, and infections-both bacterial and fungal. Aspergillosis is the fungal infection most frequently associated with ibrutinib treatment; however, cases of pneumocystosis and cryptococcosis have also been reported. Susceptibility to cryptococcosis was suggested as early as the initial studies evaluating ibrutinib for the treatment of various lymphoid malignancies. Since its widespread adoption in 2016, cases of Cryptococcosis in patients receiving ibrutinib have been reported, either as individual case reports (involving one to three patients) or within observational studies. An Australian study described the characteristics of 426 HIV-negative patients with cryptococcosis; among them, 12 were being treated with ibrutinib, representing the largest cohort to date.
While there appears to be an association between cryptococcosis and BTKi treatment, the literature on this subject is very limited, consisting only of a few clinical cases and case series, as previously mentioned. The circumstances of onset, clinical presentations, and prognosis of these cryptococcosis cases remain poorly understood. Furthermore, there are no guidelines regarding whether to continue BTKi therapy after the infection has resolved.
A better understanding of this condition in the context of this targeted therapy will improve patient management, particularly regarding diagnosis and prognosis Cryptococcosis.
- Conditions
- Cryptococcosis
- Keywords
- Cryptococcosis, Fungal infection, BTK inhibitor, Inbrutinib
- Medical subject headings
- Cryptococcosis, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients infected with cryptococcosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical manifestations description of cryptococcosis
Number of clinical manifestations and description of cryptococcosis at the time of diagnosis in patients with hematologic malignancies treated with BTK inhibitors.
Measured: 1 day
Infection sites of cryptococcosis
Type of infection sites in cryptococcosis patients at the time of diagnosis in patients with hematologic malignancies treated with BTK inhibitors.
Measured: 1 day
Microbiological and mycological data description of cryptococcosis
Microbiological and mycological data in cryptococcosis patients at the time of diagnosis in patients with hematologic malignancies treated with BTK inhibitors.
Measured: 1 day
Biological parameters of cryptococcosis
Biological parameters of cryptococcosis at the time of diagnosis in patients with hematologic malignancies treated with BTK inhibitors.
Measured: 1 day
Secondary outcomes (6)
Patients' baseline characteristics
Description of the patients' baseline characteristics, including :
- demographic characteristics,
- comorbidities,
- type of hematologic malignancy,
- history and lines of prior treatment, particularly immunosuppressive therapies;
Measured: 12 months
Time between cryptococcosis relative to the initiation of BTK inhibitor
Time to onset of cryptococcosis relative to the initiation of BTK inhibitor (BTKi) treatment by collecting patient's medical history
Measured: 12 months
Clinical cryptococcosis
Symptoms and collection of the cryptococcosis by collecting patient's medical history
Measured: 12 months
Therapeutic management
Therapeutic management of the cryptococcosis by collecting patient's undergone treatments
Measured: 12 months
Mortality
All-cause mortality by collecting patient's life status
Measured: 12 months
Treatment outcome
Outcome of BTKi treatment, including discontinuation, continuation, or resumption of treatment following the cryptococcosis episode.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for CryptococcosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Olivier PACCOUD, Study director, Assistance Publique - Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881055
- Sponsor's protocol ID
- APHP260545
- Other IDs
- N° CER-MIT
- Acronym
- CRYPTONIB
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Advani RH, Buggy JJ, Sharman JP, Smith SM, Boyd TE, Grant B, Kolibaba KS, Furman RR, Rodriguez S, Chang BY, Sukbuntherng J, Izumi R, Hamdy A, Hedrick E, Fowler NH. Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol. 2013 Jan 1;31(1):88-94. doi: 10.1200/JCO.2012.42.7906. Epub 2012 Oct 8.
PubMed 23045577O'Brien S, Furman RR, Coutre SE, Sharman JP, Burger JA, Blum KA, Grant B, Richards DA, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Izumi R, Hamdy A, Chang BY, Graef T, Clow F, Buggy JJ, James DF, Byrd JC. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial. Lancet Oncol. 2014 Jan;15(1):48-58. doi: 10.1016/S1470-2045(13)70513-8. Epub 2013 Dec 10.
PubMed 24332241Byrd 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, Furman RR, Coutre SE, Flinn IW, Burger JA, Blum KA, Grant B, Sharman JP, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Sukbuntherng J, Chang BY, Clow F, Hedrick E, Buggy JJ, James DF, O'Brien S. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013 Jul 4;369(1):32-42. doi: 10.1056/NEJMoa1215637. Epub 2013 Jun 19.
PubMed 23782158Treon SP, Tripsas CK, Meid K, Warren D, Varma G, Green R, Argyropoulos KV, Yang G, Cao Y, Xu L, Patterson CJ, Rodig S, Zehnder JL, Aster JC, Harris NL, Kanan S, Ghobrial I, Castillo JJ, Laubach JP, Hunter ZR, Salman Z, Li J, Cheng M, Clow F, Graef T, Palomba ML, Advani RH. Ibrutinib in previously treated Waldenstrom's macroglobulinemia. N Engl J Med. 2015 Apr 9;372(15):1430-40. doi: 10.1056/NEJMoa1501548.
PubMed 25853747Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Li L, Zhang L, Newberry K, Ou Z, Cheng N, Fang B, McGreivy J, Clow F, Buggy JJ, Chang BY, Beaupre DM, Kunkel LA, Blum KA. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013 Aug 8;369(6):507-16. doi: 10.1056/NEJMoa1306220. Epub 2013 Jun 19.
PubMed 23782157Burger JA, Keating MJ, Wierda WG, Hartmann E, Hoellenriegel J, Rosin NY, de Weerdt I, Jeyakumar G, Ferrajoli A, Cardenas-Turanzas M, Lerner S, Jorgensen JL, Nogueras-Gonzalez GM, Zacharian G, Huang X, Kantarjian H, Garg N, Rosenwald A, O'Brien S. Safety and activity of ibrutinib plus rituximab for patients with high-risk chronic lymphocytic leukaemia: a single-arm, phase 2 study. Lancet Oncol. 2014 Sep;15(10):1090-9. doi: 10.1016/S1470-2045(14)70335-3. Epub 2014 Aug 20.
PubMed 25150798Devirgiliis V, Panasiti V, Borroni RG, Rossi M, Curzio M, Riggio R, Fioriti D, Nicosia R, Pietropaolo V, Tecca M, Chiarini F, Innocenzi D, Calvieri S. Cutaneous cryptococcosis in a patient affected by chronic lymphocytic leukaemia: a case report. Int J Immunopathol Pharmacol. 2008 Apr-Jun;21(2):463-6. doi: 10.1177/039463200802100227.
PubMed 18547493Okamoto K, Proia LA, Demarais PL. Disseminated Cryptococcal Disease in a Patient with Chronic Lymphocytic Leukemia on Ibrutinib. Case Rep Infect Dis. 2016;2016:4642831. doi: 10.1155/2016/4642831. Epub 2016 Sep 14.
PubMed 27703818Messina JA, Maziarz EK, Spec A, Kontoyiannis DP, Perfect JR. Disseminated Cryptococcosis With Brain Involvement in Patients With Chronic Lymphoid Malignancies on Ibrutinib. Open Forum Infect Dis. 2017 Feb 9;4(1):ofw261. doi: 10.1093/ofid/ofw261. eCollection 2017 Winter.
PubMed 28480254Varughese T, Taur Y, Cohen N, Palomba ML, Seo SK, Hohl TM, Redelman-Sidi G. Serious Infections in Patients Receiving Ibrutinib for Treatment of Lymphoid Cancer. Clin Infect Dis. 2018 Aug 16;67(5):687-692. doi: 10.1093/cid/ciy175.
PubMed 29509845Coussement J, Heath CH, Roberts MB, Lane RJ, Spelman T, Smibert OC, Longhitano A, Morrissey O, Nield B, Tripathy M, Davis JS, Kennedy KJ, Lynar SA, Crawford LC, Crawford SJ, Smith BJ, Gador-Whyte AP, Haywood R, Mahony AA, Howard JC, Walls GB, O'Kane GM, Broom MT, Keighley CL, Bupha-Intr O, Cooley L, O'Hern JA, Jackson JD, Morris AJ, Bartolo C, Tramontana AR, Grimwade KC, Au Yeung V, Chean R, Woolnough E, Teh BW, Chen SCA, Slavin MA; Australian and New Zealand Study Group for Cryptococcosis in Patients Without HIV Infection. Current Epidemiology and Clinical Features of Cryptococcus Infection in Patients Without Human Immunodeficiency Virus: A Multicenter Study in 46 Hospitals in Australia and New Zealand. Clin Infect Dis. 2023 Oct 5;77(7):976-986. doi: 10.1093/cid/ciad321.
PubMed 37235212
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features and Outcomes of Cryptococcosis Associated With Bruton Tyrosine Kinase Inhibitors: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT07881055
- Acronym / sponsor ID
- CRYPTONIB / APHP260545
- Conditions
- Cryptococcosis
- Keywords
- Cryptococcosis, Fungal infection, BTK inhibitor, Inbrutinib
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Oct 2026 (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.
The purpose of this study is to describe the clinical, biological, and radiographic characteristics at the time of cryptococcosis diagnosis, as well as the time interval between the initiation of BTK inhibitor therapy and the diagnosis of cryptococcosis.
And also, the clinical course of each patient at 12 months in order to evaluate the susceptibility to cryptococcosis correlated with BTK inhibitor therapy.
Detailed description
Cryptococcosis is a fungal infection caused by a cosmopolitan encapsulated yeast known as Cryptococcus neoformans or Cryptococcus gattii. This invasive fungal disease exhibits cerebral, cutaneous, and pulmonary tropism; in cases involving the central nervous system, the mortality rate is 100% without treatment.
Although its pathogenicity in humans has been known since 1895, its incidence rose sharply with the emergence of HIV in the 1980s. Since the advent of combination antiretroviral therapies, a new population of immunocompromised individuals-specifically solid-organ transplant recipients and patient with haematological malignancy-constitutes the at-risk group.
Ibrutinib is a targeted therapy that inhibits Bruton's tyrosine kinase (BTK)-an enzyme involved in B-cell survival, activation, proliferation, and tumorigenesis. Having demonstrated efficacy in chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenström's macroglobulinemia, it has been widely used since 2016, either as monotherapy or in combination with anti-CD20 antibodies or venetoclax. Since the introduction of ibrutinib, other BTK inhibitors (BTKi) have been developed with indications overlapping those of ibrutinib.
The side effects of ibrutinib are diverse, including diarrhea, cytopenias, cardiac rhythm disorders, and infections-both bacterial and fungal. Aspergillosis is the fungal infection most frequently associated with ibrutinib treatment; however, cases of pneumocystosis and cryptococcosis have also been reported. Susceptibility to cryptococcosis was suggested as early as the initial studies evaluating ibrutinib for the treatment of various lymphoid malignancies. Since its widespread adoption in 2016, cases of Cryptococcosis in patients receiving ibrutinib have been reported, either as individual case reports (involving one to three patients) or within observational studies. An Australian study described the characteristics of 426 HIV-negative patients with cryptococcosis; among them, 12 were being treated with ibrutinib, representing the largest cohort to date.
While there appears to be an association between cryptococcosis and BTKi treatment, the literature on this subject is very limited, consisting only of a few clinical cases and case series, as previously mentioned. The circumstances of onset, clinical presentations, and prognosis of these cryptococcosis cases remain poorly understood. Furthermore, there are no guidelines regarding whether to continue BTKi therapy after the infection has resolved.
A better understanding of this condition in the context of this targeted therapy will improve patient management, particularly regarding diagnosis and prognosis Cryptococcosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Patients infected with cryptococcosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for a cryptococcosis infection.
Key inclusion criteria (3 listed)
- Adult patient (≥18 years old)
- Patient with a diagnosis of microbiologically documented cryptococcosis (antigen, direct examination, culture) established between January 2013 and January 2024 by the clinicians treating the patient with a BTK inhibitor (BTKi)*.
Key exclusion criteria (3 listed)
- Patient objecting to the use of their data.
- Patient under legal guardianship or curatorship.
- Patient unable to provide free and informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical manifestations description of cryptococcosis
Time frame: 1 day
Number of clinical manifestations and description of cryptococcosis at the time of diagnosis in patients with hematologic malignancies treated with BTK inhibitors.
Infection sites of cryptococcosis
Time frame: 1 day
Type of infection sites in cryptococcosis patients at the time of diagnosis in patients with hematologic malignancies treated with BTK inhibitors.
Microbiological and mycological data description of cryptococcosis
Time frame: 1 day
Microbiological and mycological data in cryptococcosis patients at the time of diagnosis in patients with hematologic malignancies treated with BTK inhibitors.
Biological parameters of cryptococcosis
Time frame: 1 day
Biological parameters of cryptococcosis at the time of diagnosis in patients with hematologic malignancies treated with BTK inhibitors.
6 secondary outcomes
Patients' baseline characteristics
Time frame: 12 months
Time between cryptococcosis relative to the initiation of BTK inhibitor
Time frame: 12 months
Clinical cryptococcosis
Time frame: 12 months
Therapeutic management
Time frame: 12 months
Mortality
Time frame: 12 months
Treatment outcome
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 23045577Advani RH, Buggy JJ, Sharman JP, Smith SM, Boyd TE, Grant B, Kolibaba KS, Furman RR, Rodriguez S, Chang BY, Sukbuntherng J, Izumi R, Hamdy A, Hedrick E, Fowler NH. Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol. 2013 Jan 1;31(1):88-94. doi: 10.1200/JCO.2012.42.7906. Epub 2012 Oct 8.
- Background: PubMed 24332241O'Brien S, Furman RR, Coutre SE, Sharman JP, Burger JA, Blum KA, Grant B, Richards DA, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Izumi R, Hamdy A, Chang BY, Graef T, Clow F, Buggy JJ, James DF, Byrd JC. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial. Lancet Oncol. 2014 Jan;15(1):48-58. doi: 10.1016/S1470-2045(13)70513-8. Epub 2013 Dec 10.
- 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 23782158Byrd JC, Furman RR, Coutre SE, Flinn IW, Burger JA, Blum KA, Grant B, Sharman JP, Coleman M, Wierda WG, Jones JA, Zhao W, Heerema NA, Johnson AJ, Sukbuntherng J, Chang BY, Clow F, Hedrick E, Buggy JJ, James DF, O'Brien S. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013 Jul 4;369(1):32-42. doi: 10.1056/NEJMoa1215637. Epub 2013 Jun 19.
- Background: PubMed 25853747Treon SP, Tripsas CK, Meid K, Warren D, Varma G, Green R, Argyropoulos KV, Yang G, Cao Y, Xu L, Patterson CJ, Rodig S, Zehnder JL, Aster JC, Harris NL, Kanan S, Ghobrial I, Castillo JJ, Laubach JP, Hunter ZR, Salman Z, Li J, Cheng M, Clow F, Graef T, Palomba ML, Advani RH. Ibrutinib in previously treated Waldenstrom's macroglobulinemia. N Engl J Med. 2015 Apr 9;372(15):1430-40. doi: 10.1056/NEJMoa1501548.
- Background: PubMed 23782157Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Li L, Zhang L, Newberry K, Ou Z, Cheng N, Fang B, McGreivy J, Clow F, Buggy JJ, Chang BY, Beaupre DM, Kunkel LA, Blum KA. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013 Aug 8;369(6):507-16. doi: 10.1056/NEJMoa1306220. Epub 2013 Jun 19.
- Background: PubMed 25150798Burger JA, Keating MJ, Wierda WG, Hartmann E, Hoellenriegel J, Rosin NY, de Weerdt I, Jeyakumar G, Ferrajoli A, Cardenas-Turanzas M, Lerner S, Jorgensen JL, Nogueras-Gonzalez GM, Zacharian G, Huang X, Kantarjian H, Garg N, Rosenwald A, O'Brien S. Safety and activity of ibrutinib plus rituximab for patients with high-risk chronic lymphocytic leukaemia: a single-arm, phase 2 study. Lancet Oncol. 2014 Sep;15(10):1090-9. doi: 10.1016/S1470-2045(14)70335-3. Epub 2014 Aug 20.
- Background: PubMed 18547493Devirgiliis V, Panasiti V, Borroni RG, Rossi M, Curzio M, Riggio R, Fioriti D, Nicosia R, Pietropaolo V, Tecca M, Chiarini F, Innocenzi D, Calvieri S. Cutaneous cryptococcosis in a patient affected by chronic lymphocytic leukaemia: a case report. Int J Immunopathol Pharmacol. 2008 Apr-Jun;21(2):463-6. doi: 10.1177/039463200802100227.
- Background: PubMed 27703818Okamoto K, Proia LA, Demarais PL. Disseminated Cryptococcal Disease in a Patient with Chronic Lymphocytic Leukemia on Ibrutinib. Case Rep Infect Dis. 2016;2016:4642831. doi: 10.1155/2016/4642831. Epub 2016 Sep 14.
- Background: PubMed 28480254Messina JA, Maziarz EK, Spec A, Kontoyiannis DP, Perfect JR. Disseminated Cryptococcosis With Brain Involvement in Patients With Chronic Lymphoid Malignancies on Ibrutinib. Open Forum Infect Dis. 2017 Feb 9;4(1):ofw261. doi: 10.1093/ofid/ofw261. eCollection 2017 Winter.
- Background: PubMed 29509845Varughese T, Taur Y, Cohen N, Palomba ML, Seo SK, Hohl TM, Redelman-Sidi G. Serious Infections in Patients Receiving Ibrutinib for Treatment of Lymphoid Cancer. Clin Infect Dis. 2018 Aug 16;67(5):687-692. doi: 10.1093/cid/ciy175.
- Background: PubMed 37235212Coussement J, Heath CH, Roberts MB, Lane RJ, Spelman T, Smibert OC, Longhitano A, Morrissey O, Nield B, Tripathy M, Davis JS, Kennedy KJ, Lynar SA, Crawford LC, Crawford SJ, Smith BJ, Gador-Whyte AP, Haywood R, Mahony AA, Howard JC, Walls GB, O'Kane GM, Broom MT, Keighley CL, Bupha-Intr O, Cooley L, O'Hern JA, Jackson JD, Morris AJ, Bartolo C, Tramontana AR, Grimwade KC, Au Yeung V, Chean R, Woolnough E, Teh BW, Chen SCA, Slavin MA; Australian and New Zealand Study Group for Cryptococcosis in Patients Without HIV Infection. Current Epidemiology and Clinical Features of Cryptococcus Infection in Patients Without Human Immunodeficiency Virus: A Multicenter Study in 46 Hospitals in Australia and New Zealand. Clin Infect Dis. 2023 Oct 5;77(7):976-986. doi: 10.1093/cid/ciad321.
- Individual participant dataSharing planned: No
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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.
Olivier PACCOUD study director
Assistance Publique - Hôpitaux de Paris (AP-HP)
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 Cryptococcosis, run by Assistance Publique - Hôpitaux de Paris 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 3 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: opening soon, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain MANCHON, MD (01 44 49 52 62 ext. +33, romain.manchon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical manifestations description of cryptococcosis (time frame: 1 day). The study lists 4 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 NCT07881055, which also lists 12 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 Oct 2026.