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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? (...
A Phase I/II study of Bosutinib in pediatric patients with newly diagnosed chronic phase or resistant/intolerant Ph+ Chronic Myeloid Leukemia, study ITCC-054/COG AAML1921

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04258943

Population:

Pediatrics

Phase:

I/II

This is a study of bosutinib in pediatric patients with newly diagnosed chronic phase Ph+ Chronic Myeloid Leukemia (ND CML) and pediatric patients with Ph+CML who have received at least one prior TKI therapy (R/I CML). The purpose is to find the most favorable dose of bosutinib that we can give safely, and to find out what effects, good and/or bad, bosutinib has on children and adolescents with CML. In addition, we want to see how the body of a child or adolescent processes the drug. Are you Eligible? (Inclusion Criteria) Patients must be ≥1 and <18 years at time of informed consent...
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...
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...

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