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AAML1831: A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04293562

Population:

Pediatrics

Phase:

III

This is a Phase 3 trial that will compare the efficacy of CPX-351 (a combination of 2 standard chemotherapy medicines - Daunorubicin and Cytarabine) compared to standard chemotherapy in the treatment of Acute Myelogenous Leukemia (AML). Patients will be randomly assigned by a computer to receive treatment with either CPX-351 treatment regimen or the standard chemotherapy regimen. In addition, if testing shows that a patient's AML has a specific gene change (FLT3), then those patients will be offered treatment with a new medicine (Gilteritinib) that targets the FLT3 gene change. For all...
LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

Principal Investigator:

Justine Kahn, MD

Contact Number:

212-342-5162

NCT Number:

NCT02205762

Population:

Pediatrics

Phase:

II/III

The LCH-IV is an international, multicenter, prospective clinical study for pediatric Langerhans Cell Histiocytosis LCH (age < 18 years). LCH is a rare disease of the immune system that may affect any age group. It can affect many different organs, including the skeleton, skin, lymph nodes, liver, lungs, spleen, hematopoiesis, or central nervous system (CNS). There are two widely recognized disease extent categories: single-system LCH (involvement of a single organ or system) and multisystem LCH (involvement of 2 or more organ systems). Patients with SS-LCH of the skeleton, skin, or the...
A First-In-Human, Open-Label, Multicenter Study of VOR33 in Patients with Acute Myeloid Leukemia who are at High-Risk for Leukemia Relapse following Hematopoietic Cell Transplantation

Principal Investigator:

Markus Y Mapara, MD

Contact Number:

212-342-5162

NCT Number:

NCT04849910

Population:

Adult

Phase:

I/II

You are being asked to take part in this study because you have acute myeloid leukemia (AML). Vor Biopharma, is a company that is testing a possible new treatment for AML. This possible new treatment, is VOR33. In this study, your blood-forming stem cells will be genetically modified to become VOR33. VOR33 has not been approved by the Food and Drug Administration (FDA). This is a first time VOR33 is being studied in humans. The sponsor of this study is looking to find out if VOR33 is safe. Are you Eligible? (Inclusion Criteria) Must be between 18 to 70 years old - Have a confirmed diagnosis...
AALL1821: A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC# 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/=1 to <31 Years Old with First Relapse

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04546399

Population:

Pediatrics/Adult

Phase:

II

This is a study looking at how well the combination treatment of Blinatumomab and Nivolumab works in patients with first relapse of B-cell Acute Lymphoblastic Leukemia (B-ALL) as compared to treatment with only Blinatumomab. In addition, it is looking at what effects, good and/or bad the treatment has. First relapse means that B-ALL has come back after the initial treatment a patient received for B-ALL. All patients will receive treatment with Blinatumomab, an antibody (protein) that targets a marker on B-ALL cells and then uses your immune system to kill the B-ALL cell. Some patients will...
ANHL1931: A Randomized Phase 3 trial of Nivolumab(NSC# 748726 IND# 125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04759586

Population:

Pediatrics

Phase:

III

The purpose of this trial is to compare the effects of nivolumab with chemo- immunotherapy on people diagnosed with Primary Mediastinal B-cell lymphoma (PMBCL), an aggressive form of large B-cell lymphoma. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. These drugs effectively treat PMBCL, but are known to cause long-term side effects at high doses. Nivolumab is a type of cancer treatment which uses the immune system to fight cancer. We will be using nivolumab with chemo-immunotherapy and comparing the results with only chemo-immunotherapy in newly...
A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, andPreliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination withPembrolizumab in Patients with Solid Tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05128487

Population:

Adult

Phase:

I/II

The purpose of this study is to find out if a new investigational drug NDI-101150 is safe when given alone and in combination with pembrolizumab, and to look at the pharmacokinetics (PK, to measure how your body takes up, breaks down, and clears NDI- 101150) and the antitumor activity (to measure how NDI-101150 works in your tumors). Investigational means the drug has not been approved by the Food and Drug Administration (FDA). This is the first time that NDI-101150 is being tested in humans. NDI-101150 is a small molecule inhibitor of HPK1 (a protein that weakens the immune system). It is...
A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS5001, an Anti-ROR1 Antibody Drug Conjugate, in Patients with Advanced Solid Tumors and Lymphomas

Principal Investigator:

Hua-Jay J Cherng, MD

Contact Number:

212-342-5162

NCT Number:

NCT05279300

Population:

Adult

Phase:

I

This is a study of the experimental drug CS5001 developed by CStone pharmaceutical, in patients with advanced hematological and solid tumors. CS5001 will target certain receptors that are in high levels on cancer cells. This study will look at the anti-tumor activity of CS5001. CS5001 is not approved by any regulatory agency for the treatment of any condition. It is only available in clinical studies such as this one. To date, it has only been tested in animal studies. This is the first time that the study drug will be given to humans. Are you Eligible? (Inclusion Criteria) Are you at least...
A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)

Principal Investigator:

Dawn L Hershman, MD, MS, FASCO

Contact Number:

212-342-5162

NCT Number:

NCT04960787

Population:

Adult

Phase:

NA

Studies have shown that cancer patients and their spouses may be at high risk for financial problems because of the cost of cancer treatment. This study is being done to answer the following question: Can a financial navigation program help patients and their spouses understand and better manage the financial aspects of cancer care? A financial navigator is a person or team who work with patients and their families to help them reduce stress or hardship related to the cost of cancer treatment. Financial navigators help patients understand their out-of-pocket expenses and what their health...
Trial of a Smartphone Application to Improve Medication Adherence among Patients with Cancer

Principal Investigator:

Melissa Accordino, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

NA

The purpose of this study is to learn about the difficulties patients have with the amount of medication they are required to take and to see if a smart phone application can make that process easier for patients. Patients will be asked to use an application on their smartphone or tablet daily and to come to the clinic once a month for 3 months. Are you Eligible? (Inclusion Criteria) Do you have advanced or metastatic cancer, or a hematologic malignancy? Are you taking, or planning to take at least one oral anti-cancer drug? Do you have access to a mobile phone or tablet that can download...
Phase 1b/2 Study of Carfilzomib in Combination with Induction Chemotherapy in Children with Relapsed or Refractory Acute Lymphoblastic Leukemia

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT02303821

Population:

Pediatrics

Phase:

I

The purpose of this study is to learn more about the treatment of children and teenagers whose leukemia has come back (has relapsed) or has not gone away after other treatments (is refractory). Participants will receive the study drug, called carfilzomib in combination with standard chemotherapy, that are dexamethasone, daunorubicin , vincristine and PEG-asparaginase (VXLD backbone). The study consist of 4 periods: Screening Period, Treatment Period, End of Study Period, and Long-term Follow-up Period. Participants with stable disease or better response at the end of the Induction Cycle will...

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