Clinical Trials

Longterm Follow-up of Subjects Treated With bb2121

Rochester, MN

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Longterm Follow-up of Subjects Treated With bb2121

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study, that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B cell maturation antigen (BCMA)-expressing multiple myeloma.

bb2121 is defined as autologous T lymphocytes (T cells) transduced ex vivo with anti-BCMA02 CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or retreated if retreatment criteria are met) in parent clinical study. No investigational treatment will be administered in this study.

After completing the parent study, eligible subjects will be followed for up to 15 years after their last bb2121 infusion in the parent study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 16-001082
NCT ID:
NCT02786511
Sponsor Protocol Number:
LTF-305

A Blood Collection Protocol to Study the Immune Responses of Cancer Patients with Malignancies

Scottsdale/Phoenix, AZ, Rochester, MN

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A Blood Collection Protocol to Study the Immune Responses of Cancer Patients with Malignancies

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic Pancreatic SPORE, “Optimal Immunotargeting of MUC1 for Advanced Pancreatic Cancer” (Principal Investigator Dr. Gendler). Eligibility Criteria, keep current Eligibility Criteria, but precede by:: "Three cohorts of patients will be collected.:Cohort 1 includes (1) advanced unresectable pancreatic cancer, (2-4) advanced, unresectable breast cancer (up to 6 donors per phenotype: triple negative [HER2, estrogen and progesterone receptor (ER and PR) all negative], HER2 positive whatever the ER/PR status,, and HER2 negative/ER positive), (5) advanced, unresectable colorectal cancer, (6) advanced, unresectable ovarian cancer, (7) advanced, unresectable clear cell kidney cancer, (8) advanced, unresectable bladder cancer, (9) advanced, unresectable lung adenocarcinoma, (10) advanced, unresectable multiple myeloma. Also eligible are (11) up to 6 donors with triple negative breast cancer and (12) up to 6 donors with colorectal cancer who have no clinical evidence of residual (macroscopic) disease following an attempt to perform definitive treatment (including surgery, radiation and/or adjuvant or neoadjuvant chemotherapy). Cohort 2 includes (1) muCALR+ primary MF, and (2) muCALR+ secondary MF. Cohort 3 includes (1) CMVpp65 absent and (2) CMVpp65 present GBM.. Patients in all subcohorts except 1.11 and 1.12 currently have unresectable advanced or recurrent cancers, and may undergo the collection: (1) prior to initiation of systemic therapy; (2) if patient is already engaged in an ongoing cyclical systemic therapy, collection should be within three days prior to the end of the current therapy cycle, if necessary delayed until all clinical parameters are acceptable to proceed with the next planned cycle of therapy; (3) if patient is completing non-cyclical therapy, collection should be at least 2.5-3.0 weeks after completion of the therapy, or delayed until all clinical parameters are acceptable to proceed with any planned follow-up therapy. Patients in cohorts 1.11 and 1.12 (currently lacking detectable cancer) will undergo the collection at least 4 weeks after conclusion of therapy. In addition to belonging to one of these 16 subcohorts, patients will be required to have bloodwork demonstrating a blood hemoglobin ≥ 10 g/dL, a neutrophil count ≥ 1,500 /microliter, and platelets ≥ 100,000 /microliter, performed within 7 days prior to the collection.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Scottsdale/Phoenix, Ariz.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 15-007402
- Scottsdale/Phoenix, Arizona: 15-007402
Sponsor Protocol Number:
15-007402

A Study to Review Registry of Salivary Gland Cancers for Histopathology and How They Were Managed

Scottsdale/Phoenix, AZ

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A Study to Review Registry of Salivary Gland Cancers for Histopathology and How They Were Managed

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to review the Mayo Clinic cancer registry for patients with metastatic or non-resectable salivary gland tumors, review the histopathology and evaluate treatment approaches focusing on how they correlated with the histopathology results.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Scottsdale/Phoenix, Arizona: 15-002554
Sponsor Protocol Number:
15-002554

Study to Assess the Safety and Effectiveness of Shingrix Vaccine in Patients with Hematologic Malignancies

Rochester, MN

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Study to Assess the Safety and Effectiveness of Shingrix Vaccine in Patients with Hematologic Malignancies

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to compare the response of Shingrix vaccination among patients with untreated MBL and low-risk CLL to patients with untreated intermediate and high-risk CLL.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 18-004196
Sponsor Protocol Number:
18-004196

Follow-up Letters for Subjects in the IRB# 13-001285 "Mayo Clinic Experience with Subjects Diagnosed with Diffuse Large B-cell Lymphoma (DLBCL)" Study

Rochester, MN

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Follow-up Letters for Subjects in the IRB# 13-001285 "Mayo Clinic Experience with Subjects Diagnosed with Diffuse Large B-cell Lymphoma (DLBCL)" Study

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The longer follow-up on the subjects will improve the validity on any conclusions made from the IRB study #13-001285.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 14-007976
Sponsor Protocol Number:
14-007976

A Study to Establish An Integrated Biomarker Panel for COVID-19 Infection Risk and Severity Prediction

Jacksonville, FL, Rochester, MN

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A Study to Establish An Integrated Biomarker Panel for COVID-19 Infection Risk and Severity Prediction

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Aim 1: Determine the basal profile of non-genomic factors in patients at the time of exposure to SARS-CoV-2 and correlate with the three clinical patient outcome categories (A, B, C) as observed through their clinical course.

Hypothesis: Baseline cytokine (IL-1β, IL-6, IL-4, IL-10, IFN-g and TNF-a) and the immune cellular repertoire (helper/CD4+, cytotoxic/CD8+, T-regulatory cells, natural killer cells) constitute the inherent biologic immunity of an individual and underpins their vulnerability to SARS-CoV-2 infectivity and/or its subsequent sequalae.

Aim 2: Investigate if mutations or polymorphisms in genes (CXCR6, ACE2 and SLC6A20) linked to SARS-CoV-2 correlates with the three clinical patient outcome categories (A, B, C) as observed through their clinical course.

Hypothesis: ACE2 is a cellular receptor for SARS-CoV-2. The high binding affinity of ACE2 to SARS-CoV-2 is determined by its gene sequence and polymorphisms in the ACE2 gene itself or those that regulate ACE2 function (i.e. SLC6A20) can alter this binding potential and thus the clinical impact of the virus.

Aim 3: Develop an integrated model of non-genomic (Aim 1) and genomic (Aim 2) factors for prediction of the three potential clinical courses of an individual upon exposure to SARS-CoV-2.

Hypothesis: An integrated model incorporating quantitative analysis of cytokines/immune cells (Aim 1) and gene sequence analysis (Aim 2) will allow a more robust and accurate prediction for one of the three potential clinical courses (A, B, C) after SARS-CoV-2 exposure.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information
Jacksonville, Fla.	Closed for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 21-001923
- Jacksonville, Florida: 21-001923

Spatial and Molecular Architecture of Tumor Environments Responsive to IO (immuno-oncology) Therapy

Rochester, MN

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Spatial and Molecular Architecture of Tumor Environments Responsive to IO (immuno-oncology) Therapy

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to gain stepwise understanding of the fundamental biology governing human antitumor immunity, by systematic study of the tumor-immune interface at the level of the TME, taking advantage of the heterogeneity of different interacting tumor and immune cell subsets.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 17-004117
Sponsor Protocol Number:
17-004117

Immunogenicity and Safety of Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients with Hematologic Malignancies and Associated Precursors

Rochester, MN

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Immunogenicity and Safety of Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients with Hematologic Malignancies and Associated Precursors

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The primary objective of this study is to determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies.

Secondary objectives of this study are to assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies, analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination. compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA, and analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 20-012589
NCT ID:
NCT04748185
Sponsor Protocol Number:
20-012589

Efficacy and Safety of COVID-19 Vaccine in Cancer Patients

Jacksonville, FL

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Efficacy and Safety of COVID-19 Vaccine in Cancer Patients

Study type:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

We hypothesize that cancer patients on cytotoxic chemotherapy which affect immune response may not mount adequate immune response to COVID-19 vaccines.

Aims, purpose, or objectives:

To determine the antibody response to COVID-19 vaccine after vaccination.
To assess the adverse events of COVID-19 vaccines in cancer patients.
To determine the incidence and severity of COVID-19 infection after the vaccination.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 21-001818
NCT ID:
NCT04865133
Sponsor Protocol Number:
21-001818

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Search Results 961-969 of 969 for hematology

Longterm Follow-up of Subjects Treated With bb2121

A Blood Collection Protocol to Study the Immune Responses of Cancer Patients with Malignancies

A Study to Review Registry of Salivary Gland Cancers for Histopathology and How They Were Managed

Study to Assess the Safety and Effectiveness of Shingrix Vaccine in Patients with Hematologic Malignancies

Follow-up Letters for Subjects in the IRB# 13-001285 "Mayo Clinic Experience with Subjects Diagnosed with Diffuse Large B-cell Lymphoma (DLBCL)" Study

A Study to Establish An Integrated Biomarker Panel for COVID-19 Infection Risk and Severity Prediction

Spatial and Molecular Architecture of Tumor Environments Responsive to IO (immuno-oncology) Therapy

Immunogenicity and Safety of Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients with Hematologic Malignancies and Associated Precursors

Efficacy and Safety of COVID-19 Vaccine in Cancer Patients

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