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Research Studies

Leukemia and Lymphoma Program Research Studies

Find research studies available to children cared for by the Leukemia and Lymphoma Program team.

Existing patients or family members
New patients, referrals and second opinions

Study categories

AALL2121: SNDX-5613 for Relapsed or Refractory Leukemia

This study enrolls patients that have been diagnosed with acute leukemia associated with a KMT2A (MLL) gene rearrangement (referred to as KMT2Arearranged, or KMT2A-R). The KMT2A-R leukemia has come back after treatment (relapsed) or is not responding to treatment (it is refractory). This study involves taking a study drug called SNDX-5613. The study is divided into two phases: one in which the study drug is given in combination with chemotherapy and a phase where the study drug is given alone. The purpose of the study is to test the safety of the study drug with chemotherapy, and how well the treatment regimen works for infants and young children with relapsed or refractory KMT2A-R leukemia.

Phase: Phase II

Actively recruiting: Yes

Category: Children

Conditions: Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL), Pediatric Leukemias

Allo CD7 CAR WU-CART-007

The purpose of this study is to determine the safety and tolerability of an experimental form of therapy, known as WU-CART-007 ("study drug"). WU-CART-007 uses immune cells, called T cells, that are genetically changed to identify cancer cells. In this study, T cells are collected from a healthy human donor and have been modified in a laboratory. If the genetically changed T cells recognize and attach to cancer cells, they may have the ability to kill those cancer cells.

Patients with T-cell Acute Lymphoblatic Leukemia (T-ALL) or Lymphoblastic Lymphoma (LBL), where the disease has come back (relapsed) or has not responded to treatment (refractory) may be eligible for the study.

Phase: Phase I, Phase II

Actively recruiting: No

Category: Adults, Children

AUTO1 for B-Lymphoblastic Leukemia and B-cell Non-Hodgkin Lymphoma

The purpose of this study is to determine whether AUTO1, an experimental form of therapy, is safe and effective in helping the immune system fight cancer. AUTO1 uses immune cells, called T cells, that are collected from the blood using a process called leukapheresis and then modified in a lab to recognize and target cancer cells. These modified cells are then put back into the body through infusion.

Phase: Phase I, Phase II

Actively recruiting: Yes

Category: Children

Conditions: Acute Lymphoblastic Leukemia (ALL), Non-Hodgkin Lymphoma in Children

Chemotherapy-induced Nausea and Vomiting Control

For patients (and parents of patients) that have been diagnosed with, pediatric acute lymphoblastic leukemia (ALL), nausea and vomiting are among the most bothersome symptoms during chemotherapy treatment. The overall goal of this study is to find the best strategies used by parents and patients for managing these symptoms when receiving maintenance therapy.

Phase: N/A

Actively recruiting: Yes

Category: Adults, Children

Conditions: Acute Lymphoblastic Leukemia (ALL)

CHOP T-Cell Acute Lymphoblastic Leukemia Study (BEAM-201)

The purpose of this study is to test a cell therapy for T-Cell Lymphoblastic Leukemia or Lymphoma. The CAR T-cells are made by collecting T-cells from donors and modifying them to attach to cancer cells. CAR T-cells have been used to treat other cancers, but these cells, known as BEAM-201 cells, are an experimental treatment. The participants will be given BEAM-201 cells via an IV and then monitored for up to 12 months.

This study will assess the safety and effectiveness of BEAM-201 cells.

Phase: Phase I

Actively recruiting: Yes

Category: Adults, Children

Conditions: Acute Lymphoblastic Leukemia (ALL)

Endotheliopathy in Oncology

The purpose of this research study is to determine if certain markers in your blood are increased over the duration of your chemotherapy, especially as you get sicker, such as developing a severe infection (sepsis) or severe respiratory failure (acute respiratory distress syndrome).

Phase: Pilot

Actively recruiting: No

Category: Adults, Children

Conditions: Pediatric Leukemias, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML), Juvenile Myelomonocytic Leukemia (JMML), Non-Hodgkin Lymphoma in Children, Hodgkin Lymphoma

Fludarabine/Cytarabine/Gemtuzumab Ozogamicin With or Without Venetoclax in Relapsed AML

This study involves taking a study drug called venetoclax with or without standard of care chemotherapy. The overall goal of this study is to see if adding venetoclax to standard chemotherapy leads to improved survival for children and young adults with relapsed acute myeloid leukemia (AML). The study may last up to 9 years and will enroll male and female patients from the ages of 29 days to 21 years of age.

Phase: Phase III

Actively recruiting: Yes

Category: Adults, Children

Conditions: Acute Myelogenous Leukemia (AML)

Oral Asciminib in CML

This study involves taking a study drug called asciminib. The overall goal of the study is to find out how safe and effective the study drug is in treating people that have been diagnosed with Chronic Myeloid Leukemia (CML) and have not responded to treatment.

Phase: Phase I, Phase II

Actively recruiting: Yes

Category: Children

Phase 2 trial of CART19 for Orphan Indications Of Pediatric B Cell Acute Lymphoblastic Leukemia (B-ALL)

This is an open-label, four-cohort, phase 2 study to determine the efficacy of CART19 in pediatric and young adult patients with hypodiploid (Cohort A) or t(17;19) B-ALL (Cohort B), infants with very high risk KMT2A B-ALL (Cohort C), and in patients with central nervous system (CNS) relapse who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT) (Cohort D). Possible procedures include medical record review, apheresis, CART19 infusion, blood draws, physical exams, imaging, and disease assessments through bone marrows and lumbar punctures. If interested in the study or if you have any questions, please contact 267-426-0762.

Phase: Phase II

Actively recruiting: Yes

Category: Adults, Children

Conditions: Acute Lymphoblastic Leukemia (ALL), Pediatric Leukemias

Prodigy huCART19

CAR T cell therapy has shifted the treatment landscape for pediatric and young adult patients with advanced B-cell leukemias. However, the manufacturing process remains in its first generation: difficult, time-consuming, and not automated. The time and significant resources in this process can result in patient safety issues - with patients growing sicker, with harder to control leukemias - in the waiting period. Use of the CliniMACS Prodigy platform can help to surmount these issues. This study will determine the safety and usefulness of using the CliniMACS Prodigy platform to manufacture huCART19 cells.

This is a Phase 1/2b trial for the treatment of patients with either advanced or refractory B cell Acute Lymphoblastic Leukemia or B-lineage lymphoblastic lymphoma who will be treated with huCART19, which has been manufactured using the CliniMACs Prodigy Platform. Possible procedures include medical record review, apheresis, huCART19 infusion, blood draws, physical exams, imaging, and disease assessments through bone marrows and lumbar punctures. Overall, approximately 89 subjects will be enrolled on this clinical trial.

Phase: Phase I, Phase II

Actively recruiting: Yes

Category: Adults, Children

Conditions: Acute Lymphoblastic Leukemia (ALL)

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