Clinical Trials

The purpose of this study is a national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. 

The aim of this study is to study the efficacy and safety of our short and long one-day protocols for TMP-SMX graded administration in hematologic malignancy, hematopoietic stem cell transplant, and solid organ transplant patients.    

The purpose of this study is to improve existing tools for predicting the risk of sleep apnea, as these tools are not validated in this population who have complex physiology relating to sleep.

This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.

The purposes of this study are to establish breath sample collection and analysis techniques, to establish reference ranges for selected clinical populations, and to assess correlations between breath analysis and presence or absence of clinical or pathological evidence of disease.

The purpose of this study is to assess the feasibility of utilizing virtual nephrology clinical encounters to examine clinician perceptions of patient-clinician relationships during kidney transplantation evaluations.

Although survivorship recommendations have been developed in areas such as lymphoma and stem cell transplant, the long-term effects of CAR-T therapy are unknown. In addition, relatively little is known about the psychosocial impact of CAR-T on survivors and their caregivers. Due to the intensive nature of CAR-T treatment and its unique side effects, including neurotoxicity in the acute setting and infections and financial burden in the long-term setting, a longitudinal study that assesses these issues in a quantitative and qualitative fashion is required. Consideration of both patient and caregiver needs is important for the provision of appropriate and effective health services, particularly in intensive cancer treatments that require a caregiver, such as CAR-T.

Our objective in this proposal is to define the long-term needs of CAR-T survivors using patient-reported health-related quality of life (QOL) measures, qualitative interviews, and adverse event data. The rationale for our proposed study is that it will provide the necessary knowledge on CAR-T survivor physical, mental, and social health to formulate a CAR-T specific survivorship program that can be implemented and studied in the future.

We aim to recruit 100 subjects (50 survivors and 50 caregivers) to the study. Inclusion Criteria are the following:  age ≥ 18, blood cancer diagnosis (including B-ALL, multiple myeloma, and lymphoma), receiving a CAR-T product, able to complete a written questionnaire in English either independently or with assistance, and able to perform a verbal interview either in person or via phone teleconference. We will survey patients at baseline and then at pre-specified timepoints up to 2 years after CAR-T. Survey questionnaires that have been previously validated in cancer populations will be used to assess: overall quality of life, psychosocial impact, cognitive function, post-traumatic stress, spiritual well-being, and financial toxicity. Patient demographics, adverse events, and comorbidities will also be collected via survey and/or medical record review. A selected subset of participants (10 survivors and 10 caregivers) will be chosen to undergo semi-structured open ended interviewing to obtain a qualitative understanding of unmet needs, social support, and distress. Data will be analyzed and compared to historical lymphoma and transplant cohorts.

The purpose of this study is to investigate expression of LKB1 in exosomes in urine and plasma of kidney transplant recipients and define its impact on development of interstitial fibrosis and tubular atrophy (IFTA).

The purpose of this study is to develop single chain variable fragment antibodies against HLA A2 and test their efficacy in blocking the HLA A2 and preventing the immune response. 

The purpose of this study is to determine if specific immune signatures, indicative of a balanced immune response and graft acceptance, will distinguish tolerant patients from those requiring ongoing immunosuppressive therapy. Also, to uncover a deeper understanding if the molecular and immunological mechanisms associated with operational tolerance will uncover novel targets for therapeutic interventions, ultimately paving the way for personalized and minimally immunosuppressed liver transplant approaches.