Clinical Trials and Research

Protocol ID: AALL1732

Diseases: Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Who can participate? Ages 1 to 25

Lead Researcher: Sara Zarnegar-Lumley, MD

Clinicaltrials.gov ID: NCT03959085

Protocol ID: AALL2131

Disease: Newly diagnosed Ph+ or ABL-class Ph-like B-ALL

Who can participate? Ages 1 to 22

Lead Researcher: Loretta Li, MD

ClinicalTrials.gov ID: NCT06124157

Protocol ID: AAML1831

Disease: Acute Myeloid Leukemia

Who can participate? Age less than 22 years with de novo AML

Lead Researcher: Jenna Rossoff, MD

ClinicalTrials.gov ID: NCT04293562

Protocol ID: AALL1621

Disease: B-Acute Lymphoblastic Leukemia (B-ALL)

Who can participate? Ages 1 to 22

Lead Researcher: Joanna Weinstein, MD

ClinicalTrials.gov ID: NCT02981628

Protocol ID: AALL2121

Disease: Relapsed or refractory KMT2A-rearranged infant leukemia

Who can participate? Ages 1 month to 6 years (must have had initial diagnosis of leukemia at < 2 years old)

Lead Researcher: Sara Zarnegar-Lumley, MD

ClinicalTrials.gov ID: NCT05761171

Protocol ID: 21-757

Diseases: Hematologic Malignancies (ALL, MDS, t-AML)

Who Can Participate? Age ≤ 40 years

Lead Researcher: Loretta Li, MD

ClinicalTrials.gov ID: NCT05292664

Protocol ID: AALL1821

Disease: B-ALL 

Who can participate? Patients must be >= 1 and < 31 years at time of enrollment. Patients must have first relapse of CD19+ B-ALL. 

Lead Researcher: Jenna Rossoff, MD

ClinicalTrials.gov ID: NCT04546399

Protocol ID: APAL2020D 

Disease: Relapsed Acute Myeloid Leukemia  

Who can participate? Participants must be ≥ 29 days of age and ≤ 21 years of age at enrollment and have relapsed AML. 

Lead Researcher: Jenna Rossoff, MD

ClinicalTrials.gov ID: NCT05183035

Protocol ID: APAL2020K

Disease: Relapsed leukemia

Who can participate? Infants/children ages 0-21 years of age with KMT2A-r, NPM1-m, or NUP98-r acute leukemia in first or greater relapse or refractory disease.

Lead Researcher: Sara Zarnegar-Lumley, MD

ClinicalTrials.gov ID: NCT06376162

Protocol ID: T2020-006

Diseases: CD123+ hematologic malignancy 

Who can participate? Patients must be ≥ 1 and ≤21 years of age at the time of enrollment. Patients must have a diagnosis of Relapsed and/or refractory CD123+ hematologic malignancy (including, but not limited to, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, mixed phenotype acute leukemia, acute undifferentiated leukemia, blastic plasmacytoid dendritic cell neoplasm, Hodgkin lymphoma, and non-Hodgkin lymphoma). 

Lead Researcher: Jenna Rossoff, MD

ClinicalTrials.gov ID: NCT05476770

Protocol ID: PEPN2312 

Diseases: Acute myeloid leukemia, myelodysplastic syndrome,  juvenile myelomonocytic leukemia  

Who can participate? Patients must be ≥ 1 year and ≤ 18 years of age at the time of study enrollment and have second or greater relapsed or refractory AML, first or greater relapse of MDS, or first or greater relapse of JMML. 

Lead Researcher: Sara Zarnegar-Lumley, MD

ClinicalTrials.gov ID: NCT06247787

Protocol ID: APAL2020SC

Diseases: Relapsed Leukemias

Who can participate? Ages less than 22

Lead Researcher: Jenna Rossoff, MD

ClinicalTrials.gov ID: NCT04726241

Protocol ID: T2020-003 IDEAL2 

Diseases: B-ALL 

Who can participate? 10 - 26 years who are not underweight and in first induction. 

Lead Researcher: Jenna Rossoff, MD

ClinicalTrials.gov ID: NCT05082519

Protocol ID: AHOD2131

Disease: Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

Who can participate? Ages 5 to 60

Lead Researcher: Joanna Weinstein, MD

ClinicalTrials.gov ID: NCT05675410

Protocol ID: LCH-IV 

Disease: Langerhans cell histiocytosis 

Who can participate? Patients must be less than 18 years of age at the time of diagnosis. Patients must have histological verification of the diagnosis of Langerhans cell histiocytosis.

Lead Researcher: Joanna Weinstein, MD

ClinicalTrials.gov ID: NCT02205762

Protocol ID: NACHO-BIO

Diseases: Histiocytic Disorders 

Who can participate? Patients with confirmed or suspected diagnosis of LCH, JXG, ECD, MFRH, RDD, HLH, malignant histiocytosis or other histiocytic diseases or family members (related by blood) of patients with histiocytic diseases. 

Lead Researcher: Joanna Weinstein, MD

Protocol ID: ANHL2121

Disease: Langerhans Cell Histiocytosis

Who Can participate? 180 days- <22 years

Lead Researcher: Joanna Weinstein, MD

ClinicalTrials.gov ID: NCT02205762

A clinical trial is a research study that tests potential treatments in study participants who volunteer. The intent of a clinical trial is to identify treatment combinations/alternatives that will provide the highest efficacy or the best chance of a cure with the least number of undesirable effects. Clinical trials are important to improve health because they are the only way to find out if a potential new treatment/drug works and is safe.

Study participants are more actively involved in their own healthcare, get access to new research treatments that may be more effective than existing treatments before they are widely available, help others with the same disease, and contributing to medical research.

All clinical trials have requirements and regulations about who can participate. The criteria are based on factors such as age, stage and type of disease, previous treatment history, preexisting medical conditions, gender, and others. Before joining a clinical trial, a study participant must meet the study’s eligibility criteria, which is used to identify the appropriate participant population and keep them safe.

Study participants learn about risks during the informed consent process when a detailed description of the trial goals and processes are explained. Participants can always ask for more information at any time during the clinical trial.

There are four different phases of clinical trials used to evaluate new treatments for childhood cancers, as well as other diseases. Each phase has a different objective.

• Phase I: is the first and most basic step of clinical trials and involves the smallest group of participants (20 – 100). Phase I evaluates treatment dosage and severe side effects.
• Phase II: evaluates whether the treatment works and if it causes severe or new side effects, and it involves 100 – 300 study participants.
• Phase III: during this clinical trial is confirmed if the treatment/drug works and is safe. This phase compares the current treatment against promising treatment alternatives that may increase cure rates (efficacy) or decrease undesirable effects or late effects of treatment. This trial involves the greater number of participants, and it determines whether the FDA approves the treatment for more people to use.
• Phase IV: or pharmacovigilance, this phase evaluated treatment after it has been FDA approved to monitor new treatment’s side effects over a long period of time.

The first step is to talk to your healthcare provider; they know your health condition and may be able to recommend a clinical trial for your consideration.

If you would like more information about a clinical trial for childhood leukemia, lymphoma, or histiocytosis at Lurie Children’s, you may email us at Advanced_Leukemia_Program@luriechildrens.org. A member of our team will respond within 2 business days.