Northwestern University Feinberg School of Medicine

Clinical Trials

All Clinical Trials

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Prospective, Observational, Long-term Follow-up Study for Subjects who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study A non-therapeutic, long-term follow-up study, following patients who previously received zamtacabtagene autoleucel (also referred to as MB-CART2019.1) in a US Miltenyi Biomedicine-sponsored clinical study for potential gene therapy-related adverse events (AEs) until 15 years after treatment with zamtocabtagene autoleucel. Who Can Participate? Eligibility Criteria Some of the eligibility criteria include: · Age of at least 18 years · Previous treatment with zamtacabtagene autoleucel (also referred to as MB-CART2019.1) Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial. Principal Investigator, Study ID, Keywords Principal Investigator Karmali, Reem ClinicalTrials.gov IdentifierNCT06116110 IRB number STU00222107 Click to Copy URL to Clipboard View More
The CLICK Study- a digital mental health app for adults with schizophrenia What is this study about? The purpose of this study is to evaluate a digital mental health application for adults with schizophrenia who are experiencing social withdrawal, reduced emotions and decreased motivation. This application will be added to the current antipsychotic therapy treatment. What will I do if I participate? Participants will take part in 4 study visits in-person at Northwestern Hospital and 3 remote visits over the course of 4 months. Visits will include clinical assessments and questionnaires regarding mental health symptoms. In addition, participants will use the digital application daily for 5-30 minutes. Who Can Participate? Eligibility Criteria Eligibility: 18 years of age or older , Diagnosed with Schizophrenia Study duration=16 weeks Principal Investigator, Study ID, Keywords Principal Investigator Rado, Jeffrey Thomas ClinicalTrials.gov IdentifierNCT05838625 IRB number STU00218871 Click to Copy URL to Clipboard Location(s) 680 N. Lake Shore Dr. Chicago, IL For questions about this study, contact: Email Stein, Eve Phone 312 503 7071 View More
(xIRB ) DRUG DB-1303-O-3002: A Phase 3, Randomized, Multi-center, Open-label Study of DB-1303 Versus Investigator’s Choice Chemotherapy in Human Epidermal Growth Factor Receptor 2 (HER2)-low, Hormone Receptor Positive (HR+) Metastatic Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy (ET) (DYNASTY-Breast02) The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry [IHC]2+/in situ hybridization [ISH]- and IHC 1+) population. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial. Who Can Participate? Eligibility Criteria Some of the eligibility criteria include: · Participants must have a diagnosis of Metastatic Breast Cancer · Participants must be 18 or older Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial. Principal Investigator, Study ID, Keywords Principal Investigator Gradishar, William J ClinicalTrials.gov IdentifierNCT06018337 IRB number STU00221757 Click to Copy URL to Clipboard Location(s) 1000 N. Westmoreland Road North Entrance Lake Forest, IL 304 Randall Road Geneva, IL 4405 Weaver Pkwy Warrenville, IL 10 Health Services Drive DeKalb, IL 251 E. Huron St. Fifth Floor, Suite 704 Chicago, IL View More
(xIRB NCI CIRB) Alliance A092105: Randomized Phase 2 Study of Nivolumab and Ipilimumab with or Without Cabozantinib in Patients with Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy This phase II trial compares the effect of treatment with palbociclib alone to treatment with palbociclib plus cemiplimab for treating patients with dedifferentiated liposarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cemiplimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. The combination of these two drugs may be more effective in shrinking or stabilizing advanced dedifferentiated liposarcoma compared to palbociclib alone. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial. Who Can Participate? Eligibility Criteria Some of the eligibility criteria include: · Participants must have a diagnosis of advanced dedifferentiated liposarcoma · Participants must be 18 or older Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial. Principal Investigator, Study ID, Keywords Principal Investigator Lorch, Jochen Hanns-Martin ClinicalTrials.gov IdentifierNCT05904080 IRB number STU00220532 Click to Copy URL to Clipboard Location(s) 201 E. Huron St. Chicago, IL 304 Randall Road Geneva, IL 4405 Weaver Pkwy Warrenville, IL 2701 Patriot Blvd. Glenview, IL 1475 E. Belvidere Road Grayslake, IL 10 Health Services Drive DeKalb, IL 1000 N. Westmoreland Road Lake Forest, IL View More
(xIRB NCI CIRB) CCTG NE1: NET RETREAT: A Phase II Study of 177 Lutetium-DOTATATE Retreatment vs. Everolimus in Metastatic/Unresectable Midgut NET This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus in patients who have previously received 177Lu-DOTATATE for midgut neuroendocrine tumor (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable). PRRT is a type of radiation therapy for which a radioactive chemical is linked to a peptide (small protein) that targets cancer cells. When this radioactive peptide is injected into the body, it binds to a specific receptor found on some cancer cells. The radioactive peptide builds up in these cells and helps kill the cancer cells without harming normal cells. In this trial 177Lu-DOTATATE is used for PRRT. 177Lu-DOTATATE PRRT may increase the length of time until the midgut NET worsens compared to the usual approach. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping cancer cells from reproducing and by decreasing the blood supply to the cancer cells. Retreating with 177Lu-DOTATATE may work better than everolimus in shrinking or stabilizing tumor in patients with metastatic and unresectable NET who were previously treated with 177Lu-DOTATATE. Who Can Participate? Eligibility Criteria · Participants must have a diagnosis of metastatic midgut neuroendocrine tumor · Participants must be 18 or older Principal Investigator, Study ID, Keywords Principal Investigator Benson III, Al B ClinicalTrials.gov IdentifierNCT05773274 IRB number STU00219981 Click to Copy URL to Clipboard Location(s) 201 E. Huron St. Chicago, IL Keywords Phase 2 177Lu-DOTATATE Everolimus midgut neuroendocrine tumor For questions about this study, contact: Email Study Coordinator Phone 312 695 1102 View More
(xIRB NCI CIRB) ECOG-ACRIN 9213: A Phase II Study of Daratumumab-Hyaluronidase for Chemotherapy-Relapsed/Refractory Minimal Residual Disease (MRD) in T Cell Acute Lymphoblastic Leukemia (T-ALL) This study is being done to answer the following question: Can daratumumab-hyaluronidase reduce the level of MRD in T-ALL patients previously treated with chemotherapy? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your T-ALL. The usual approach is defined as care most people get for Acute Lymphoblastic Leukemia (ALL). The usual approach for patients who are not in a study is treatment with chemotherapy, and possibly stem cell transplant. Sometimes, combinations of these treatments are used. Currently there is no SOC treatment for MRD positive T ALL. Many patients if eligible would undergo stem cell transplant, but still have a high risk for T ALL relapse if MRD positive The purpose of this study is to test the good and bad effects of the drug called daratumumab and hyaluronidase. Daratumumab and hyaluronidase could be effective in preventing your cancer from returning, but it could also cause side effects. The study doctors hope to learn if the study drug will be effective in treating patients with MRD positive T-ALL and preventing reoccurrence of your disease. Who Can Participate? Eligibility Criteria Patient must be ≥ 18 years of age Patient must have documented T cell ALL and must be in first or later hematologic CR or CRi after a minimum of 2 blocks of intensive chemotherapy Patients in hematologic CR or CRi must have persistent or recurrent MRD ≥ 10−4 Patient may have undergone a prior allogeneic stem cell transplant, but patient may not have Grafts Versus Host Disease (GVHD) that requires ongoing immunosuppressive therapy. Patient may receive prednisone if the dose is ≤ 10 mg per day Principal Investigator, Study ID, Keywords Principal Investigator Dinner, Shira Naomi ClinicalTrials.gov IdentifierNCT05289687 IRB number STU00217578 Click to Copy URL to Clipboard For questions about this study, contact: Email Study Coordinator Phone 312 695 1102 View More
(xIRB NCI CIRB) ECOG-ACRIN EA1211: Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT Trial This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial. Who Can Participate? Eligibility Criteria Some of the eligibility criteria include: · Participants must have a diagnosis of HER2-positive stage IIa-IIIc breast cancer · Participants must be 18 or older Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial. Principal Investigator, Study ID, Keywords Principal Investigator Stein, Regina M ClinicalTrials.gov IdentifierNCT05710328 IRB number STU00219917 Click to Copy URL to Clipboard Location(s) 201 E. Huron St. Chicago, IL For questions about this study, contact: Email Garcia, Nina J Phone 312 695 1356 View More
(xIRB NCI CIRB) ETCTN 10237: A Phase 1 Study of TAK-243 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes with Increased Blasts This phase I trial studies the side effects and best dose of TAK-243 in treating patients with acute myeloid leukemia or myelodysplastic syndromes with increased blasts that has come back (relapsed) or that is not responding to treatment (refractory). TAK-243 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial. Who Can Participate? Eligibility Criteria Some of the eligibility criteria include: · Participants must have a diagnosis of (AML or MDS) with increased blasts (MDS-IB) assessed by local laboratory review according to the 2022 World Health Organization (WHO) criteria for myeloid neoplasms. Both patients with MDS-IB1 (5-9% bone marrow blasts) and MDS-IB2 (10-19% bone marrow blasts) are eligible. · Patients must have relapsed or refractory disease after receiving at least one prior line of therapy Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%). · Participants must be 18 or older Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial. Principal Investigator, Study ID, Keywords Principal Investigator Atluri, Himachandana ClinicalTrials.gov IdentifierNCT03816319 IRB number STU00223000 Click to Copy URL to Clipboard Location(s) 251 E. Huron St. Fifth Floor, Suite 704 Chicago, IL View More
(xIRB NCI CIRB) ETCTN 10486: Phase 2 Trial of the Combination of the BET inhibitor, ZEN003694 (ZEN-3694), and the PARP Inhibitor Talazoparib, in Patients with Molecularly-Selected Solid Tumors (ComBET) This phase II trial tests whether ZEN003694 (ZEN-3694) in combination with talazoparib works to shrink tumors in patients with solid tumors that are unlikely to be cured or controlled with treatment and may have spread to other parts of the body. Another aim of this study is to determine if and how patients' genes influence their response to this specific drug combination. ZEN-3694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Talazoparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. It is the accumulation of DNA damage which causes a cell to change into a cancerous cell. Combination therapy with ZEN-3694 and talazoparib may be effective at slowing or stopping tumor growth in patients with advanced cancer. Note: This is only a partial description of the study. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University if you are interested in the trial. Who Can Participate? Eligibility Criteria • Participants must have a diagnosis of metastatic or unresectable cancer • Participants must be 18 or older Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial. Principal Investigator, Study ID, Keywords Principal Investigator Kalyan, Aparna ClinicalTrials.gov IdentifierNCT05327010 IRB number STU00218004 Click to Copy URL to Clipboard Location(s) 251 E. Huron St. Fifth Floor, Suite 704 Chicago, IL For questions about this study, contact: Email Patel, Yagney Govindbhai Phone 312 695 1006 View More
(xIRB NCI CIRB) ETCTN 10487: A Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer with Neuroendocrine Differentiation This phase II trial studies how well lutetium Lu 177 dotatate works in treating patients with prostate cancer with neuroendocrine differentiation (formed from cells that release hormones into the blood in response to a signal from the nervous system) that has spread to other places in the body (metastatic). Radioactive drugs, such as lutetium Lu 177, may carry radiation directly to tumor cells and not harm normal cells. The study aims to determine if this approach is better or worse than the usual approach for prostate cancer. Who Can Participate? Eligibility Criteria • Participants must have a diagnosis of prostate cancer with neuroendocrine differentiation. • Participants must be 18 or older Principal Investigator, Study ID, Keywords Principal Investigator Hussain, Maha ClinicalTrials.gov IdentifierNCT05691465 IRB number STU00219572 Click to Copy URL to Clipboard Location(s) 201 E. Huron St. Chicago, IL Keywords Phase 2 lutetium Lu 177 dotate Radioactive drugs View More

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