Clinical Research Directory

Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event

Background: Drugs or cell therapies to treat cancer can sometimes cause cytokine release syndrome (CRS). That is, the body makes too many cytokines after treatment. Cytokines are proteins that play a role in the immune system. CRS can cause fever, chills, fatigue, low blood pressure, or breathing problems. Researchers want to know if continuously monitoring a person s body temperature can help reduce the chance of getting serious CRS. Objective: To learn if an approved patch called TempTraq can detect fever before serious CRS develops. Eligibility: People aged 18 years and older with cancer who are staying at the NIH clinic for treatment with drugs or cell therapies. Design: Participants will receive TempTraq patches and a special NIH tablet. The TempTraq is a small patch applied to clean, dry skin under the arm. It continually monitors body temperature and sends the data to an application on the tablet. Participants will wear the patch most of the time they are admitted to the hospital. They could wear it for up to 15 days. The patch monitoring does not replace regular temperature checks, all participants will still have have their regular temperature checks as part of their treatment plan. Participants may also opt to use VitalTraq, another application on the tablet. They will hold the screen up to their face for about 1 minute. VitalTraq uses the camera in the tablet to measure blood pressure, heart rate, and breathing. They will do this once per day while they are in the clinic; they may do it more often if they have a fever or feel unwell. Blood may be drawn for research. Participants will be asked about their experience within 1 week after TempTraq is removed. Participants who choose to use the patch, complete its use, and return at a later date for another treatment or study, may be able to re-enroll to have the patch used again.

Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma

This phase Ib trial studies the side effects and best dose of copanlisib and nivolumab and side effects of copanlisib given together with nivolumab and ipilimumab in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or lymphoma. Copanlisib stops tumors from growing by blocking proteins that are known to be important for tumor cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving copanlisib together with nivolumab or with nivolumab and ipilimumab may work better in treating patients with solid tumors or lymphoma.

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

This phase II MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in patients with solid tumors, lymphomas, or multiple myelomas that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and does not respond to treatment (refractory). Patients must have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas

Background: The drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers. They want to study its effects on cancers that may have not responded to chemotherapy or other treatments. Objectives: To see if Nivolumab slows the growth of some types of cancer or stops them from getting worse. To test the safety of the drug. Eligibility: People 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders or EBV-positive non-Hodgkin lymphomas with no standard therapy Design: Participants will be screened with: Medical history Physical exam Blood and urine tests CAT scan of the chest, abdomen, and pelvis Tumor and bone marrow biopsies (sample taken) Magnetic resonance imaging scan of the brain Lumbar puncture (also known as spinal tap) Positron emission tomography/computed tomography scan with a radioactive tracer Every 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also have: Physical exam Blood and pregnancy tests Review of side effects and medications During the study, participants will repeat most of the screening tests. They may also have other biopsies. After stopping treatment, participants will have a visit every 3 months for 1 year. Then they will have a visit every 6 months for years 2-5, and then once a year. They will have a physical exam and blood tests.

Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis

Background: \- Some genes may be associated with a greater chance of side effects during cancer treatment. These genes may also make certain treatments less effective. Researchers want to collect blood or cheek swab samples from people having cancer treatment to study these genes. Objectives: \- To obtain a blood or cheek swab sample to study genetic differences that may affect cancer treatment. Eligibility: \- Individuals with cancer who are being treated at the National Cancer Institute. Design: * Participants will provide a blood sample for study. * Participants who have blood-based cancer, such as leukemia, will provide a cheek swab sample. * If the blood or cheek swab sample does not have enough genetic material for analysis, an additional sample may be collected.

Study of CAR-T Therapy in Older Patients

This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.

Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy

Background: CAR T-cell therapy is a promising new treatment for blood cancers. During treatment, a person s T-cells are genetically changed to kill cancer cells. Researchers want to learn more about the effects of potential problems that may be associated with this treatment. We are specifically interested in learning if and how this treatment may affect the brain or your thinking skills. Objective: To learn if CAR T-cell therapy can affect how children and adults think, process, and remember things. Eligibility: People aged 5-35 who have blood cancer that has not responded to treatment, or the blood cancer has come back after treatment, and who will receive CAR T-cell therapy. Caregivers are also needed. All participants must be able to speak and read in English or Spanish. Design: Participants will be screened with a medical history. Information from participants medical records will be collected. Participants will take tests at home or at NIH to see how well they think, read, learn, remember, reason, and pay attention. The tests will be both computerized and paper/pencil. They will take less than 1 hour to complete. Participants and a parent/adult observer will complete a 5-minute Background Information Form and a checklist of nervous system symptoms. If participants are 5 years or older, they will participate in activities to test their ability to do different thinking tasks, like answer questions, complete puzzle patterns, and remember things. Participants and their caregivers will complete questions to see if they are having specific symptoms related to receiving CAR T-cells. The questions will assess their well-being and needs. The questions will take less than 1 hour to complete. Some tests and questions will be repeated at different time points in the study. Participation will last for up to 3 years.

A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype

The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal T cell lymphoma with TFH phenotype.

Sample Collection and Tracking for the Developmental Therapeutics Clinic

Background: People who join a study in the Developmental Therapeutics Clinic (DTC) have tests. These include blood draws and biopsies. Researchers collect data from these samples. Some people take part in more than one study at the DTC. At this time, data are connected only with one single study. Researchers want to access people s medical records. This will allow them to link the research data from all their studies they have or will take part in. Researchers also want to collect medical data about their diagnosis and treatment history. This will allow them to see how their cancer reacted to different drugs over time. Objective: To enter people into a master protocol to connect research sample and treatment data across DTC studies. Eligibility: People ages 18 and older who are being evaluated or treated for cancer in the DTC Design: Participants will allow researchers to look at all the data from their research samples. This includes those from their current, past, and any future NIH studies. Participants will allow researchers to access some of their medical data. This includes age, diagnosis, treatment history, and response to treatment. Participants will provide no new samples. ...

A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And Lymphomas

This is an open-label, single institution, Phase 1 study of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult participants with relapsed or refractory T-ALL or T-LBL

Anti-CD30 biAb-AATC in Patients With Relapsed/Refractory CD30 Positive Hematopoietic Malignancies

This first-in-human trial will assess the safety, feasibility, and efficacy of an immunotherapy with a novel CD30 antibody conjugated to a CD3 antibody that is preloaded onto a patient's own T-cells, generating a CD30 bispecific antibody-armed, anti-CD3-activated, autologous T-cells (CD30 biAb-AATC).

A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma

Background: B-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the system that fights infections and disease. Researchers want to learn how certain drugs work together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR). Objective: To study the safety of ViPOR for people with B-cell lymphoma. Eligibility: People ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after treatment Design: Participants will be screened with: * Medical history * Physical exam * Blood, urine, and heart tests * Tissue sample from previous procedure * Imaging scans * Registration for counseling on the risks of lenalidomide. They must get counseling at least every 28 days. Participants will have a bone marrow aspiration before treatment. Participants may have tumor samples taken. Participants will get ViPOR in 21-day cycles. For up to 6 cycles: * Participants will get one drug by IV on days 1 and 2. * Participants will take the other four drugs by mouth on most days. After their first dose of venetoclax, they will stay in the clinic for at least 8 hours and return the next day for monitoring. They may be admitted for more drugs or monitoring. Participants will keep a drug diary. Participants will have a physical exam and blood and urine tests at least once per cycle. They will have scans 4 times over 6 cycles. Participants will have a visit about 1 month after their last dose of study drug. They will then have visits every few months for 3 years, and once a year for years 4 and 5. Visits include a physical exam, blood tests, and scans.

Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing

Background: Leukapheresis is a procedure to separate and collect white blood cells. It is the first step in a treatment called CAR (chimeric antigen receptor) T-cell therapy. CAR-T therapy may be offered to people when their cancer comes back. The collected T-cells are used to make a special version of T-cells called CARs. Researchers want to collect these cells from people who may become eligible for a CAR T-cell study in the future. Objective: To identify people who have a high likelihood to benefit from CAR T-cell therapy early in their disease course and collect and store a T-cell product. Eligibility: People ages 3-65 with a form of leukemia or lymphoma that has not been cured by standard therapy Design: Participants will be screened with medical history, physical exam, and blood and urine tests. Review of existing MRI, x-ray, pathology specimens/reports or CT images may be done. On this study, participants will have leukapheresis. A needle will be placed into the arm. Blood will be collected and go through a machine. White blood cells will be taken out by the machine. The plasma and red cells will be returned to the participant through a second needle in the other arm. The procedure will take 4-6 hours. Some participants may have a central line (catheter) inserted which is needed to do the leukapheresis procedure, instead of the needles in the arms-especially if they are smaller. For a central line placement, a long thin tube is inserted through a small incision into the main blood vessel leading into the heart that would allow access to the blood to do the leukapheresis procedure. Participants cells will be processed and frozen for future use in a CAR T-cell therapy study.

Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors

The goal of this clinical trial is to learn if a mind body resilience group program can help increase lymphoma survivors' ability to cope with and manage the challenges that come with the transition into early post treatment survivorship.

TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) as first-line treatment of patients with diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL).

A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship

The goal of this trial is to learn if a resilience intervention can lead to improvements in lymphoma survivors' quality of life.

A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma

A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.

A Study of CPI-613 for Patients With Relapsed or Refractory Burkitt Lymphoma/Leukemia or High-Grade B-Cell Lymphoma With High-Risk Translocations

The purpose of this study is to test any good and bad effects of the study drug, CPI-613.

Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma

The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.

TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas

The primary purpose of this study is to evaluate the safety, pharmacokinetics,, and preliminary anti-tumor activity of TLN-121 as a single agent and in combination with other anti-lymphoma therapies in patients with relapsed or refractory Non-Hodgkin Lymphomas

An AI-Generated, Personalized Question Prompt List Intervention for Patients With Hematologic Cancers

The goal of this study is to evaluate the feasibility and preliminary efficacy of an artificial intelligence (AI)-generated personalized question prompt list (a list of suggested questions to ask during outpatient appointments) for patients with hematologic cancers. The intervention will involve tailoring a standardized prompt to patients' individual characteristics and concerns. This prompt will then be used to ask Washington University's (WashU) HIPAA compliant ChatGPT to generate personalized question lists for outpatient appointments. Analyses will assess the impact of personalized QPLs on patients' question-asking behavior; communicative self-efficacy; and self-reported amount and satisfaction with information obtained about their disease and its treatment. Sub-analyses will explore patterns in questions generated by WashU ChatGPT. Patients will also provide feedback pertaining to the perceived helpfulness and ease-of-use of WashU-ChatGPT-generated question lists, as well as their attitudes and intentions regarding use of AI chatbots and whether they would engage in pre-appointment AI-assisted question brainstorming independently in the future.

A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma

The purpose of this study is to evaluate the safety and efficacy of lisocabtagene maraleucel (Breyanzi/liso-cel/BMS-986387) in adults as first-line treatment in transplant-ineligible Primary Central Nervous System Lymphoma (PCNSL).