An observational study in Cryptococcosis, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
546 studies on the registry are indexed under Mycoses; 56 are open to participants now.
This study's planned enrollment of 30 is below the median of 153 across 153 observational studies indexed under Mycoses.
Browse Mycoses studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated for a cryptococcosis infection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)*.
Exclusion Criteria:
Patients infected with cryptococcosis
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day
Biological parameters of cryptococcosis
Biological parameters of cryptococcosis at the time of diagnosis in patients with hematologic malignancies treated with BTK inhibitors.
Time frame: 1 day
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;
Time frame: 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
Time frame: 12 months
Clinical cryptococcosis
Symptoms and collection of the cryptococcosis by collecting patient's medical history
Time frame: 12 months
Therapeutic management
Therapeutic management of the cryptococcosis by collecting patient's undergone treatments
Time frame: 12 months
Mortality
All-cause mortality by collecting patient's life status
Time frame: 12 months
Treatment outcome
Outcome of BTKi treatment, including discontinuation, continuation, or resumption of treatment following the cryptococcosis episode.
Time frame: 12 months
Plan to share: No
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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