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A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 inPatients with Mature B-Cell Malignancies

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT04277637

Population:

Adult

Phase:

I

The purpose of this study is to look at the safety and tolerability of an investigational anticancer drug currently known as BGB-11417. This study aims to determine the range of BGB-11417 doses that can safely be used, the safest dosing schedule to minimize side effects when first taking BGB-11417, what side effects may be experienced when taking this drug, how your body processes this drug, and if this drug is effective against your cancer. Are you Eligible? (Inclusion Criteria) Provision of signed and dated written informed consent prior to any study specific procedures, sampling, or...
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
Double-blind, randomized, placebo-controlled, prospective Phase III study evaluating efficacy and safety of Panzyga in Primary Infection Prophylaxis in patients with Chronic Lymphocytic Leukemia (“PRO-SID” study)

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT04502030

Population:

Adult

Phase:

III

This study will be performed to determine if Panzyga (the study drug) can help with preventing infections in patients who have chronic lymphocytic leukemia (CLL). The immune system is a bodily system that protects the body from foreign substances, infection agents, cells, and tissues. When the immune system does not work properly, it´s called immunodeficiency. This can be caused by hematological malignancies (forms of cancer that begin in the cells of blood-forming tissue, such as the bone marrow, or in the cells of the immune system) like chronic lymphocytic leukemia (CLL). That´...
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Patients with Acute Leukemia and Other Selected Hematologic Malignancies, with and without Mixed Lineage Leukemia (MLL)-rearrangement or Nucleophosmin 1 (NPM1) Mutation

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT04988555

Population:

Adult

Phase:

I/II

You are being asked to participate in this study because you have acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or leukemia of mixed lineage (the leukemia cells cannot be classified as AML or ALL or where both types of AML and ALL cells are present). Because you have already received standard therapy that is no longer helping, or there is no standard of care for your type of leukemia at this point in your care, you are eligible to participate in a study such as this that involves an experimental drug. It is up to you and your study doctor to decide on whether to take part...
A PHASE 1/2 MULTI-CENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF KTE-X19 IN PEDIATRIC AND ADOLESCENT SUBJECTS WITH RELAPSED/REFRACTORY B-PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA OR RELAPSED/REFRACTORY B-CELL NON-HODGKIN LYMPHOMA (ZUMA 4)

Principal Investigator:

Prakash Satwani, MD

Contact Number:

212-342-5162

NCT Number:

NCT02625480

Population:

Pediatrics/Adult

Phase:

I/II

Kite Pharma, Inc., a for-profit biotechnology company, is funding this research study and has designed the trial. The sponsor is testing an experimental treatment named KTE-C19, which uses the patient’s own genetically altered blood cells to treat cancer. KTE-C19 is made from blood cells that are removed from the patient. A virus (retrovirus) is used to introduce a gene that creates a protein (called a chimeric antigen receptor or CAR) on the surface of T cells, a type of blood cell that fights infection and eliminates cancer cells. The main purpose of this research study is to...
A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) plus Venetoclax and Rituximab versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-322)

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT04965493

Population:

Adult

Phase:

III

The purpose of this study is to test the safety and effectiveness of an investigational treatment called pirtobrutinib (LOXO-305) plus venetoclax and rituximab (PVR) versus venetoclax and rituximab (VR). Pirtobrutinib is an investigational (or experimental) drug that may treat your Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Are you Eligible? (Inclusion Criteria) Age 18 and older at time of enrollment. Confirmed diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). Able to swallow oral study medication.
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT04623541

Population:

Adult

Phase:

I/II

The purpose of this study is to investigate the safety and tolerability of the study drug, epcoritamab, as a treatment for Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome. This means the study will look into the potential side effects of epcoritamab and how well it works against your disease. This study will also measure epcoritamab levels in your blood and how long epcoritamab stays in your body. Are you Eligible? (Inclusion Criteria) • Must be at least 18 years of age • Women can not be pregnant • Male and Women of child bearing potential must agree to...
AALL1721: A phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy

Principal Investigator:

Prakash Satwani, MD

Contact Number:

212-342-5162

NCT Number:

NCT03876769

Population:

Pediatrics/Adult

Phase:

II

The purpose of this study is to find out if the study drug, tisagenlecleucel, is safe and has benefits for people who have high-risk B-cell Acute Lymphoblastic Leukemia (B-ALL) and have a tiny number of leukemia cells still present in their bone marrow (MRD positive) at the end of consolidation (EOC) therapy. Tisagenlecleucel is a product made up of the patient's own T cells that have been changed to be able to identify and kill leukemia cells. Patients will receive chemotherapy followed by tisagenlecleucel and then be monitored to see how well the treatment worked. Are you Eligible? (...
Sequential Assessment of Minimal Residual Disease by Next Generation Sequencing to Optimize Outcomes and Minimize Exposure in Venetoclax-Treated CLL/SLL Patients

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT04419519

Population:

Adult

Phase:

II

The purpose of this study is to find out whether people who are currently receiving treatment with venetoclax can stop treatment and remain off-treatment for at least 12 months, if they are free of residual disease (MRD- negative) when they stop treatment. Are you Eligible? (Inclusion Criteria) > 18-years-old Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma confirmed by the enrolling institution Receiving treatment with a venetoclax-based regimen as defined below: - Venetoclax monotherapy (therapy that uses one type of treatment) Venetoclax in combination with anti...
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...

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