Phase 1 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 years or older
• People whose treating doctor has determined they are not eligible for, or have already tried, standard treatments with established benefits
• People diagnosed with one of the following conditions who meet the specific disease-related criteria listed below:
  • Erdheim-Chester disease, Langerhans histiocytosis, histiocytic sarcoma, or other malignant histiocytosis — without certain specific gene changes (BRAF or MAP2K activating alterations) — whose disease has come back or stopped responding after at least one prior treatment
  • Newly diagnosed Rosai-Dorfman disease without activating MAP2K gene changes
  • Rosai-Dorfman disease that has come back or stopped responding, with a specific MAPK pathway gene change, and where prior treatment with cobimetinib has not worked
  • Erdheim-Chester disease or Langerhans histiocytosis previously treated with vemurafenib (for a specific gene mutation called BRAF V600E) or cobimetinib (for MAP2K gene changes)
  • Erdheim-Chester disease, Rosai-Dorfman disease, Langerhans histiocytosis, histiocytic sarcoma, or other malignant histiocytosis in people who cannot tolerate, have a medical reason to avoid, or cannot reliably access BRAF or MEK inhibitor treatments due to financial or geographic barriers, or where those treatments are considered unlikely to help based on the person's specific gene changes or the treating doctor's judgement
  • Higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), or myelofibrosis (MF) that has come back or stopped responding — MF patients must have already tried at least one of four specific FDA-approved JAK inhibitor medicines; MDS and CMML patients must have tried a type of treatment called hypomethylating agent therapy if considered appropriate by their doctor
  • T cell lymphoma (including peripheral and cutaneous types) or mantle cell lymphoma, after at least two prior treatments
  • Primary central nervous system (CNS) lymphoma, after at least two prior treatments
  • Follicular lymphoma, or Waldenström macroglobulinemia/lymphoplasmacytic lymphoma, that has come back or stopped responding, after at least two prior treatments
  • Waldenström macroglobulinemia in people who have already received, or are not considered appropriate for, a type of treatment called a BTK inhibitor
  • Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or stopped responding, after at least two prior treatments including at least one BTK inhibitor and/or BCL2 inhibitor, with documented need for treatment according to established guidelines
• People whose diagnosis has been confirmed by laboratory testing of tissue or cell samples
• People willing to provide blood, bone marrow, saliva, and tissue samples for research purposes, as relevant to their condition
• People able to swallow pills
• People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out at least some daily activities, confirm with trial site)
• People with a life expectancy of at least 3 months
• People with disease that can be measured or assessed — for histiocytic and lymphoma conditions, this means at least one area of disease visible on CT or MRI scan measuring at least 1.5 cm, or confirmed by biopsy on PET/CT scan; for CNS-involved disease, any size on MRI is acceptable; for other eligible conditions, formal measurement may not be required (confirm with trial site)
• People with blood test results within acceptable ranges, taken within 14 days before joining the trial, including: haemoglobin at least 8.0 g/dL; neutrophil count at least 1.0 x 10⁹/L; platelet count at least 80 x 10⁹/L; white blood cell count at least 2.5 x 10⁹/L; bilirubin no more than 1.5 times the upper limit of normal; liver enzyme levels (ALT, AST, ALP) no more than 2.5 times the upper limit of normal (or up to 5 times if the liver is directly affected by the disease); kidney function tests within acceptable ranges
• People of childbearing potential with a negative pregnancy test taken within 7 days before joining
• Sexually active people and their partners who are willing to use an effective form of contraception throughout the trial and for at least 3 months after the last dose of the study drug
• People who are willing and able to give written informed consent
• People able to complete questionnaires on their own or with help
• People willing to return to the enrolling site for follow-up visits during the active monitoring phase of the study

Who may not be able to join:

• People with certain blood cancer types (myeloproliferative neoplasms) who have known active cancer spread to the brain or the lining of the brain or spine (note: histiocytosis and lymphoma patients on steroids may still be considered)
• People who are pregnant or currently breastfeeding
• People of childbearing potential, or people who can father a child, who are unwilling to use adequate contraception
• People with significant heart problems, including a heart attack, severe unstable chest pain, certain bypass surgeries, or heart failure that occurred within the 6 months before joining
• People with a specific abnormality in their heart's electrical activity (a QTcF interval greater than 470 msec on an electrocardiogram)
• People with certain active viral infections, including: HIV with a low immune cell count (CD4+ less than 350 cells/µL), or HIV with a detectable viral load and not on antiretroviral therapy for at least 4 weeks; active hepatitis B or C virus (people with a past history of hepatitis B or C may be considered if the virus is undetectable; people with HIV who have adequate immune function and are on active treatment may also be considered)
• People with active, uncontrolled bacterial, viral, or fungal infections that require systemic (whole-body) treatment
• People currently taking certain medications that strongly affect the way the body processes drugs (specifically strong inhibitors or inducers of CYP1A2, CYP2C19, CYP2D6, or CYP3A4 enzymes) — these must be stopped for a specific washout period before joining (confirm with trial site)
• People currently taking any herbal supplements (prior use should be discussed with the principal investigator, as a washout period may be needed)
• People who have recently received certain prior cancer treatments, including: targeted therapies (other than monoclonal antibodies) within 2 weeks; monoclonal antibody therapies within 6 weeks or 5 half-lives (whichever is shorter); chemotherapy within 4 weeks (6 weeks for certain specific chemotherapy drugs); surgery within 4 weeks; any other experimental therapy within 4 weeks; or radiation therapy within 4 weeks — some exceptions apply for palliative (symptom-relief) radiation given at least 2 weeks before joining, depending on the area treated and side effects (confirm with trial site)
• People who have not yet recovered from significant side effects of prior treatments (recovery to a mild level or back to their personal baseline is generally required, though some ongoing long-term effects such as numbness, tiredness, or appetite loss may be acceptable — confirm with trial site)
• People with other serious illnesses or conditions that, in the treating doctor's judgement, would make participation unsafe or interfere with accurately assessing the safety of the study treatment
• People with active serious eye conditions affecting the retina or cornea, such as retinitis pigmentosa, macular degeneration, retinal detachment, or an opaque cornea — some exceptions may apply for mild vision changes or people with only one assessable eye, at the discretion of an eye specialist or the principal investigator (confirm with trial site)
• People with another active cancer currently requiring treatment that would interfere with assessing the response of the primary cancer or evaluating the safety of the study treatment

Important: Always verify eligibility with the trial site directly before applying.