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A Phase I, Open-Label Dose Escalation and Dose Expansion Study of Intravenous GFH009 SingleAgent in Patients with Relapsed/Refractory Hematologic Malignancies

Principal Investigator:

Andrew H Lipsky, MD

Contact Number:

212-342-5162

NCT Number:

NCT04588922

Population:

Adult

Phase:

I

The purpose of this study is to assess the safety, effectiveness, pharmacokinetic ([PK] how long the drug is in your body and how it is metabolized) and pharmacodynamics ([PD] where does the drug go in your body and what is its biological effect) of the study drug, GFH009, in patients with relapsed or refractory hematologic malignancies including acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or other lymphomas. This is the first time GFH009 is being studied in humans. Are you Eligible? (Inclusion Criteria) or older. 2. Have cytological or...
A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients with Advanced Systemic Mastocytosis

Principal Investigator:

Mark L. Heaney, MD

Contact Number:

212-342-5162

NCT Number:

NCT04996875

Population:

Adult

Phase:

II

The purpose of this study is to: • to determine the optimal dose of oral CGT9486 in patients with Advanced Systemic Mastocytosis (AdvSM). • to determine the efficacy of CGT9486 at the selected optimal dose in patients with Advanced Systemic Mastocytosis (AdvSM). Are you Eligible? (Inclusion Criteria) Age ≥18 years of age Have a form of Advanced Systemic Mastocytosis (including Aggressive Systemic Mastocytosis, Advanced Systemic Mastocytosis with an Associated Hematologic Neoplasm, or Mast Cell Leukemia). Measurable disease, per Diagnosis of Systemic Mastocytosis (SM) criteria.
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...
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 I multi-dose study of human placental hematopoietic stem cell derived natural killer cells (CYNK-001) in adults with primary or secondary acute myeloid leukemia (AML) in morphologic complete remission with minimal residual disease (MRD)

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT04310592

Population:

Adult

Phase:

I

The purpose of this clinical research study is to evaluate the safety (any good or bad effects) of CYNK-001 and to assess the effects of CYNK-001 on your Acute Myeloid Leukemia (AML). Also, the study plans to determine the maximum tolerated dose (highest safe dose) of CYNK-001 and assess whether CYNK-001 can eliminate your residual (leftover) disease. CYNK-001 has not been approved by the FDA for the treatment of cancer or any other disease and its use in this study is investigational. About 22 patients in the US will take part in this study. Are you Eligible? (Inclusion Criteria) Are you...
A Phase 1/2, Multi-center, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination with Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric

Contact Number:

(212) 342-5162

NCT Number:

NCT03793478

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find the best dose of Quizartinib that can be given safely with chemotherapy in children and young adults with acute myeloid leukemia (AML) which has come back or has not responded to the standard therapy. Quizartinib will be given by mouth once a day from Day 6 through Day 28. It will be given in combination with chemptherapy drugs cytarabine and fludarabine. Are you Eligible? (Inclusion Criteria) Patients must have recurrent or refractory AML Patients must be between 1 month and ≤21 years of age Patients must also meet all eligibility criteria as outlined...
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 1B TRIAL OF HU5F9-G4 MONOTHERAPY OR HU5F9-G4 IN COMBINATION WITH AZACITIDINE IN PATIENTS WITH HEMATOLOGICAL MALIGNANCIES

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

(212) 342-5162

NCT Number:

NCT03248479

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of an experimental drug called Hu5F9-G4 in patients with blood cancers such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). This study will enroll 2 different groups of patients: Relapsed/Refractory (R/R) and Treatment-naïve Unfit (TN/U) The use of Hu5F9-G4 in this research study is experimental, which means that the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) has not approved its use for cancer treatment or treatment of any other disease. Are you Eligible? (Inclusion Criteria) Subject must...
Phase I Trial of Fedratinib in Combination with Decitabine in Patients with Myeloproliferative Neoplasms in Accelerated and Blast Phase

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

I

You are being asked to participate in this study because you have a myeloproliferative neoplasm (MPN) that has transformed to accelerated or blast phase. MPN is a group of diseases in which the bone marrow makes too many blood cells. The different types of MPN are myelofibrosis (MF), essential thrombocythemia (ET), or polycythemia vera (PV). Over time, these diseases may become harder to treat by entering an accelerated or blast phase. These phases occur when the bone marrow makes too many immature cells called blasts. Blasts are not fully developed and cannot carry out any particular...
A Phase I/II Dose-Escalation and Expansion Study of the Selective PKC-β Inhibitor MS-553 in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT03492125

Population:

Adult

Phase:

I

that is known to play a role in the growth and survival of cancer cells in different types of leukemia.The purpose of this study is to determine the safety, recommended dose and preliminary activity of MS-553 in treating CLL/SLL. Are you Eligible? (Inclusion Criteria) Are you at least 18 years of age? Do you have CLL or SLL?

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