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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? (...
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...
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...
AAML18P1: Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03817398

Population:

Pediatrics/Adult

Phase:

II

This is a pilot study in pediatric and young adult patients with chronic phase CML (CML-CP) who are currently being treated with a tyrosine kinase inhibitor (TKI). Treatment with a TKI is currently life long. Pediatric patients with CML have long life spans, therefore they will be taking a TKI for a long time, especially during periods of growth and development, and therefore are believed to be at a significantly increased risk for side effects. Patients in this study will stop taking TKI medication and be closely monitored for 3 years to see if they remain cancer free. If their CML returns,...
AALL1631: International Phase 3 trial in Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL) testing Imatinib in combination with two different cytotoxic chemotherapy backbones

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT03007147

Population:

Pediatrics/Adult

Phase:

III

This phase 3 study is examining the best treatments for Philadelphia chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL). The goal of this study is to see if using a less toxic chemotherapy regimen in combination with Imatinib can effectively treat standard risk Ph+ ALL. Patients with high risk Ph+ ALL will receive more intensive chemotherapy followed by stem cell transplant. Are you Eligible? (Inclusion Criteria) must be at least greater than 1 year and less than 21 years of age Patients must be newly diagnosed Patients must also meet all eligibility criteria as outlined in the study...
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...
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...
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...
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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