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Long-Term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated with Gene-Modified Cells

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT05041309

Population:

Adult

Phase:

II

The purpose of this study is to monitor you for any delayed side effects that may possibly be related to the experimental gene-modified therapy product you received in the Kite-sponsored study for Axicabtagene ciloleucel (“axi-cel”). The main study does not involve treatment. In the re-treatment portion, you will be provided access to a second course of treatment with lymphodepleting chemotherapy and axi-cel. Axi-cel is manufactured using your own blood cells. If you meet the requirements for the retreatment part of this study, the study doctor will confirm if leftover product...
MRD-GUIDED SEQUENTIAL THERAPY FOR DEEP RESPONSE IN NEWLY DIAGNOSED MULTIPLE MYELOMA - MASTER-2 TRIAL

Principal Investigator:

Rajshekhar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT05231629

Population:

Adult

Phase:

II

The purpose of the study is to determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who are MRD “positive” at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD “negative” with autologous hematopoietic cell transplantation (AHCT) plus a new immunotherapy called teclistamab in combination with...
Open Label Phase II Trial of Cabozantinib in Patients withMetastatic Castrate Resistant Prostate Cancer (mCRPC) andKnown Amplifications or Activating Mutations in Gene Targets of Cabozantinib who have Received Prior Anti Androgen Therapy

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT04631744

Population:

Adult

Phase:

II

The purpose of this study is to determine what effects (good and bad) cabozantinib has in treatment of prostate cancer. Cabozantinib (Cometriq™, Cabometyx™) is an oral medication that blocks activity of specific proteins in the body. It is approved by the Food and Drug Administration (FDA) for use in patients with medullary thyroid carcinoma and advanced renal cell carcinoma but is not approved to treat prostate cancer. Are you Eligible? (Inclusion Criteria) Age >18 years. Evidence of metastatic Prostate Cancer on imaging (bone scan and/or CT/MRI scan) • Previously...
Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06667076

Population:

Adult

Phase:

II

The purpose of this study is to understand more about the combination of amivantamab and lazertinib in non-small cell lung cancer (NSCLC) who have a specific mutation in the EGFR (epidermal growth factor receptor) gene and have not had prior treatment for their disease. The Food and Drug Administration (FDA) has not approved the combination of amivantamab subcutaneous (given as an injection under the skin) and lazertinib. Are you Eligible? (Inclusion Criteria) must be 18 years old or older - must not be currently enrolled in another investigational study - must agree to use sun protection...
Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma

Principal Investigator:

Kazuki Sugahara, MD, PHD

Contact Number:

212-342-5162

NCT Number:

NCT03127774

Population:

Adult

Phase:

II

motherapy can improve survival in patients with metastatic adrenal cortical carcinoma. Are you Eligible? (Inclusion Criteria) * Histologically proven ACC with the majority of disease confined to the peritoneal cavity and resectable; or disease that in the opinion of the investigators can be managed medically or surgically and does not present an immediate threat to the patientâs life. * Disease evaluable by CT or PET imaging * All disease should be deemed resectable based on imaging studies e.g.: - Hepatic metastases (unilateral or bilateral â¤5 lesions, â¤...
Phase II, Neoadjuvant study of parasympathetic stimulation with bethanechol in combination with gemcitabine and nab-paclitaxel in borderline resectable pancreatic adenocarcinoma

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT05241249

Population:

Adult

Phase:

II

of this study is to determine whether the drug, bethanechol, could potentially be used in combination with chemotherapy regimen gemcitabine and nab-paclitaxel and surgery to decrease the chance of the cancer coming back after it is removed. Animal models have shown that treatment with bethanechol can inhibit cancer growth and spread. The chemotherapy regimen nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer is FDA approved. Although bethanechol is FDA approved, in this study its use is experimental. The aim of the study is to show that...
Phase II study of Polatuzumab vedotin in combination with chemotherapy in subjects with Richter's Transformation

Principal Investigator:

Andrew H Lipsky, MD

Contact Number:

212-342-5162

NCT Number:

NCT04679012

Population:

Adult

Phase:

II

This research is being done because Richter’s transformation, which is a life- threatening complication of chronic lymphocytic lymphoma (CLL), and is associated with poor overall survival rate. The study drug administration is a combination of the investigational drug, Polatuzumab vedotin, in combination with Rituximab, Etoposide, Prednisone, Cyclophosphamide, and Hydroxydaunorubicin, also referred to as PolaR-EPCH. An investigational drug means it has not been approved by the FDA or any other international regulatory agencies. The purpose of this study is to find out what effects the...
Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04726241

Population:

Pediatrics/Adult

Phase:

II

This study is called a screening study and the purpose of this study to find better ways to diagnose and treat leukemia that has come back after treatment or difficult to treat. Bone marrow, blood, and medical information about cancer and treatment will be collected. The results from this screening study may give other information about leukemia that is important when deciding how to best treat leukemia. Are you Eligible? (Inclusion Criteria) Patients must be 21 years of age or younger Patient must have one of the following: A. Patient has known or suspected relapsed/refractory (including...
Pembrolizumab in combination with gemcitabine for previously treated mycosis fungoides and Sezary syndrome: efficacy and characterization of immune response

Principal Investigator:

Larisa J Geskin, MD

Contact Number:

212-342-5162

NCT Number:

NCT04960618

Population:

Adult

Phase:

II

Primary objective: Determine preliminary clinical effectiveness of pembrolizumab plus gemcitabine in previously treated MF and SS with overall response rate (ORR) using the composite global response criteria including: radiological imaging (PET/CT scans), flow cytometry and mSWAT assessments. 2. Secondary objectives: a. To estimate duration of response (DOR) of pembrolizumab plus gemcitabine in previously treated MF and SS. b. To estimate progression-free survival (PFS) pembrolizumab plus gemcitabine in previously treated MF and SS. c. To estimate overall survival (OS) of patients with...
Phase II single arm study testing SBRT, Adenosine signaling Modulation (AB680, AB928), and Immune Checkpoint inhibition (AB122) for men with hormone sensitive Oligometastatic prostate cancer (SBRT-AMICO)

Principal Investigator:

Catherine S Spina, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05915442

Population:

Adult

Phase:

II

This study aims to test the safety and effectiveness of zimberelimab, etrumadenant, and quemliclustat when given together with radiotherapy as a potential treatment to hormone sensitive oligometastatic (cancer that has spread to other areas of the body) prostate cancer. Zimberelimab, etrumadenant, and quemliclustat are considered immunotherapy drugs. These type of drug works by blocking a protein that can cause tumors to grow. By blocking this protein, the study drugs may cause your cancer to stop growing or to shrink. These study drugs are not approved by Health Authorities including the...

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