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A Phase II Randomized Study Comparing Ibrutinib and Rituximab vs. Venetoclax and Rituximab in Previously Untreated Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL)

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT04840602

Population:

Adult

Phase:

II

The purpose of this study is to compare the usual treatment alone to using venetoclax plus the usual treatment. The addition of venetoclax to the usual treatment could shrink the cancer. But, it could also cause side effects. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the drug combination of venetoclax with ibrutinib and rituximab shrinks and prevents the return of Waldenström's Macroglobulinemia/Lymphoplasmacytic Lymphoma compared to the usual...
A Randomized Phase II trial of consolidation therapy following CD19 CAR T-cell treatment for Relapsed/Refractory Large B-cell Lymphoma or Grade IIIB Follicular Lymphoma

Principal Investigator:

Hua-Jay J Cherng, MD

Contact Number:

212-342-5162

NCT Number:

NCT05633615

Population:

Adult

Phase:

II

This study is being done to answer the following question: Can we lower the chance of Diffuse Large B-cell Lymphoma (DLBCL) cancer growing or spreading by adding treatment to the usual therapy? This study is being done to find out if this approach is better or worse than the usual approach for DLBCL patients receiving chimeric antigen receptor (CAR) T-cell therapy. The usual approach for Relapsed/Refractory DLBCL patients who have a partial response or stable disease after CAR T-cell therapy is follow-up visits with no further therapy. Some patients will improve their response over time, but...
A phase 2 randomized study of osimertinib versus osimertinib plus chemotherapy for patients with metastatic EGFR-mutant lung cancers that have detectable EGFR mutant cfDNA in plasma after initiation of osimertinib treatment

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04410796

Population:

Adult

Phase:

II

This study will compare the effectiveness of osimertinib alone to the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene for the epidermal growth factor receptor (EGFR). Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. This study will be adding chemotherapy to osimertinib, which could possibly add to the anticancer effects of the usual treatment and may help stop cancer from growing or spreading. Osimertinib binds to the EGFR protein and blocks its activity,...
A PHASE II OPEN-LABEL, SINGLE CENTER TRIAL OF ORAL DECITABINE-CEDAZURIDINE (INQOVI®) IN COMBINATION WITH THIOGUANINE (TABLOID®) IN PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT06351306

Population:

Adult

Phase:

II

You are being asked to participate in this study because you have acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory). The purpose of the study is to see how safe and effective the combination of decitabine- cedazuridine and thioguanine is in treating your cancer. Are you Eligible? (Inclusion Criteria) At least 18 years of age or older 2. Are you able to give written informed consent and be able to comply with all study requirements? 3. Subjects must have adequate organ function
A Phase 2 Study of Neoadjuvant PARP Inhibition followed by Radical Prostatectomy in Patientswith Unfavorable Intermediate-Risk or High-Risk Prostate Cancer with BRCA1/2 GeneAlterations (NePtune)

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05498272

Population:

Adult

Phase:

II

This is a research study to find out if giving a drug called olaparib with a Luteinizing hormone- releasing hormone (LHRH) agonist (medication that suppresses testosterone) before you undergo a radical prostatectomy (surgery to remove your prostate) decreases the amount of cancer present at the time of surgery and decrease the risk of the disease coming back after surgery. You will receive one of the LHRH agonist: leuprolide, triptorelin or goserelin. Olaparib, leuprolide, triptorelin and goserelin is FDA approved for several types of cancers such as certain types of ovarian, breast,...
Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial (ARCITECT)

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05928806

Population:

Adult

Phase:

II

The purpose of this study is to find out if the combination of botensilimab and balstilimab is more effective and safer at treating in clear cell Renal Cell Cancer (ccRCC) [kidney cancer] that has spread to other parts of the body (metastatic) than the standard combination of nivolumab and ipilimumab. The combination of nivolumab and ipilimumab has already been approved by the Food and Drug Administration (FDA) for use in advanced kidney cancer. The combination of balstilimab and botensilimab is investigational and has not been approved by the Food and Drug Administration (FDA). Are you...
A Phase II Trial of Durvalumab with Gemcitabine and Cisplatin as Neoadjuvant Therapy for High-Risk Resectable Intrahepatic Cholangiocarcinoma

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06050252

Population:

Adult

Phase:

II

This study is being done to answer the following question: How tolerable is the new combination of durvalumab with classic chemotherapy (gemcitabine and cisplatin) before surgery for your high-risk liver cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your liver cancer. The usual approach is defined as care most people get for liver cancer. Are you Eligible? (Inclusion Criteria) Age ≥ 18 years Patients must have histologically or cytologically confirmed intrahepatic cholangiocarcinoma (iCCA) that is resectable by...
A phase 2 double-blind, RandomizEd, prospective, placebo controlled STudy of NanO2 TMcombined with Radiation and temozolomide in patients with newly-diagnosed glioblastomamultiformE: RESTORE

Principal Investigator:

Maria Diaz Ordonez, MD

Contact Number:

212-342-5162

NCT Number:

NCT03862430

Population:

Adult

Phase:

II

The main purpose of this study is to test a new study drug called NanO2, along with the standard chemotherapy and radiation therapy that is used to treat newly diagnosed Glioblastoma Multiforme and determine its safety and ability to improve the effectiveness of radiation and chemotherapy on newly diagnosed Glioblastoma Multiforme. The drug used in this study is an investigational treatment, which has not been approved by the United States Food and Drug Administration (FDA) to treat this or any other disease. The study drug, NanO2, is being developed to see if it can increase the...
A PHASE II RANDOMIZED, OPEN-LABEL, TRIAL OF NAB-PACLITAXEL + GEMCITABINE WITH OR WITHOUT BOTENSILIMAB (AGEN1181) IN PATIENTS WITH METASTATIC PANCREATIC CANCER WHO HAVE PROGRESSED ON PRIOR 5FU + LEUCOVORIN + IRINOTECAN + OXALIPLATIN (FOLFIRINOX)

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05630183

Population:

Adult

Phase:

II

The purpose of this study is to find out if study drug, botensilimab, when given in combination with chemotherapy consisting of nab-paclitaxel + gemcitabine, can help patients with metastatic pancreatic cancer. Botensilimab has not been approved by US Food and Drug Administration (FDA). Nab-paclitaxel + gemcitabine is an approved chemotherapy combination for pancreatic cancer, but they are not FDA approved to treat pancreatic cancer that has progressed after receiving initial treatment. This trial consists of two parts (Part 1 and Part 2). All visits and procedures are the same in both parts...
A RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEMACABTAGENE ANSEGEDLEUCEL IN PARTICIPANTS WITH MINIMAL RESIDUAL DISEASE AFTER RESPONSE TO FIRST LINE THERAPY FOR LARGE B-CELL LYMPHOMA (ALPHA3)

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

Population:

Adult

Phase:

II

The study aims to see if CAR T cells made from healthy donors are an effective study treatment to prevent relapse in participants who have lymphoma DNA detected in their blood by an investigational test. The study evaluates two investigational products – ALLO- 647, an antibody (protein) that may help prepare the body for receiving CAR T cells from healthy donors, and a CAR T cell study treatment called cemacabtagene ansegedleucel or cema-cel. Both ALLO-647 and cema-cel are investigational drugs and therefore not approved by the Food and Drug Administration (FDA). For reference, CAR T...

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