Phase 1 Peripheral Arterial 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:

• Adults aged 18 or older
• People with multiple myeloma (a type of blood cancer) that has come back or stopped responding to treatment, and who have previously been treated with three specific types of therapy: an immunomodulatory drug, a proteasome inhibitor, and an alkylating agent
• People with certain types of T-cell lymphoma (a cancer of the immune system) that has come back after standard treatment, or where standard treatment did not work — and who have either tried or are not eligible for a stem cell transplant (depending on the specific lymphoma type)
• People with certain types of B-cell lymphoma (another immune system cancer), other than Burkitt's lymphoma, at any stage (for specific groups only)
• People with certain rare cancers called histiocytic or dendritic cell neoplasms (for specific groups only)
• People whose liver enzyme levels (ALT and AST) are within an acceptable range, tested within 15 days before joining
• People whose kidney function (creatinine level) is within an acceptable range, tested within 15 days before joining
• People whose liver function markers (bilirubin, and clotting-related tests) are within acceptable ranges, tested within 15 days before joining
• People with pre-existing liver disease must have a liver health score no worse than "Class A" on a standard medical scale (confirm with trial site)
• People who test negative for pregnancy (if there is any possibility of pregnancy), tested within 15 days before joining
• People with multiple myeloma who have measurable signs of disease detectable through specific blood, urine, or protein tests
• People with multiple myeloma who have blood cell counts (white cells, platelets, and haemoglobin) above certain minimum levels, tested within 14 days before joining
• People with T-cell or B-cell lymphoma who have measurable disease visible on a CT or MRI scan — at least one area of disease larger than 2 cm — or detectable cancer cells in the blood; skin lesions of sufficient size may also count if photographed with a ruler and documented in medical records
• People with histiocytic or dendritic cell neoplasms who have measurable disease of at least 1.5 cm, or detectable cancer cells in the blood, with similar documentation requirements for skin lesions
• People with no active spread of cancer to the brain or spinal cord (central nervous system)
• People who are able to give written consent to participate
• People who are willing to return to Mayo Clinic for follow-up visits
• People with a life expectancy of at least 12 weeks
• People with a general health and activity level rated as 0, 1, or 2 on a standard medical performance scale (meaning able to carry out at least some daily activities)
• People willing to provide biological samples (such as blood or tissue) for research purposes

Who may not be able to join:

• People for whom a curative treatment is available and acceptable to them
• People with an active, uncontrolled infection
• People with active tuberculosis, active hepatitis, or chronic hepatitis
• People who have recently received certain cancer treatments — chemotherapy (including immunomodulatory drugs, alkylating agents, or proteasome inhibitors) within the past 2 weeks, immunotherapy (monoclonal antibodies) within the past 4 weeks, or an experimental treatment within a specific timeframe based on how long that drug stays in the body (confirm with trial site)
• People with significant heart problems, including serious heart failure (classified as Grade III or IV), known or suspected coronary artery disease, or certain irregular heart rhythms such as atrial fibrillation or a rapid heartbeat condition called supraventricular tachycardia
• People with an active brain or nervous system disorder, seizure disorder, or known neurological disease or symptoms; for those with AML, active cancer involvement in the brain or spinal cord as detected by a lumbar puncture or brain scan (if clinically needed)
• People who test positive for HIV, or who have another condition that weakens the immune system
• People who are currently receiving other chemotherapy, immunotherapy, radiation, or any other experimental treatment at the same time — with specific exceptions allowed for hydroxyurea in AML (to manage high cell counts) and certain skin care products for T-cell lymphoma to manage itching or prevent infection (no topical chemotherapy is allowed)
• Women who are pregnant
• Women who are able to become pregnant and are unwilling to use effective contraception during the trial
• Women who are breastfeeding
• Men who are unwilling to use a condom during sex while taking the study drug and for 4 weeks after stopping, regardless of prior vasectomy
• People with AML who currently have a serious blood-clotting disorder called disseminated intravascular coagulation (DIC)
• For specific trial groups, people with a diagnosis of AML, Burkitt's lymphoma, or certain specific lymphoma types may not be eligible (the exact restrictions depend on which group a person would be assigned to — confirm with trial site)
• For the multiple myeloma low-tumour-burden group: people with more than 25% plasma cells in the bone marrow, or a tumour mass larger than 5 cm
• For low-tumour-burden lymphoma or histiocytic/dendritic cell neoplasm groups: people with any single mass larger than 5 cm
• For the T-cell lymphoma expansion group: people with cutaneous (skin-based) T-cell lymphoma

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