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Diagnostic Testing for Pediatric Leukemia

Phase 1 & 2

Recruiting

Led By Michele S Redell

Research Sponsored by LLS PedAL Initiative, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be less than 22 years of age at the time of study enrollment

Known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trialaims to find better ways to diagnose and treat pediatric leukemias using clinical and biological data. Testing bone marrow may help doctors decide how to best treat patients.

Who is the study for?

This trial is for children, adolescents, and young adults under 22 with leukemia that's come back or is hard to treat. They must have consent from parents/guardians if needed, meet FDA and NCI human study requirements, and have specific types of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), mixed phenotype acute leukemia (MPAL), juvenile myelomonocytic leukemia (JMML), or relapsed ALL.Check my eligibility

What is being tested?

The trial involves collecting bone marrow and blood samples from patients to understand the clinical and biological characteristics of their acute leukemias. This information may help determine eligibility for other sub-trials aimed at finding better ways to diagnose and treat pediatric leukemia.See study design

What are the potential side effects?

Since this trial focuses on biospecimen collection rather than drug treatment, typical side effects associated with medications are not a concern here. However, there might be general discomforts related to sample collection such as pain or bruising at the needle site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am under 22 years old.

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My leukemia linked to Down syndrome has returned or is not responding to treatment.

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I have been diagnosed with juvenile myelomonocytic leukemia.

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My AML cancer has returned or didn't respond to treatment.

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My leukemia has returned or didn't respond to treatment.

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I have AML or MDS that is new, has come back, or didn’t respond to treatment.

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I have a new or returning myelodysplastic syndrome that is resistant to treatment.

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My leukemia has returned after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial

Side effects data

From 2024 Phase 2 trial • 86 Patients • NCT03201458

74%

Disease Progression

47%

Fatigue

35%

Aspartate aminotransferase (AST) increased

33%

Abdominal pain

33%

Diarrhea

30%

Hypertension

30%

Lymphocyte count decreased

30%

Anemia

28%

Hyponatremia

28%

Alkaline phosphatase increased

28%

Nausea

26%

Hypoalbuminemia

26%

Hypokalemia

23%

Alanine aminotransferase (ALT) increased

23%

Vomiting

21%

Fever

21%

Platelet count decreased

21%

Anorexia

21%

Cough

19%

Pain

16%

Blood bilirubin increased

16%

Constipation

16%

White blood cell decreased

14%

Dyspnea

14%

Creatinine increased

12%

Hypomagnesemia

12%

Bloating

12%

Chills

12%

Dehyrdation

12%

Weight loss

Hypothyroidism

Rash

Dizziness

Edema

Headache

Infusion-related reaction

Hypotension

Ascites

Back pain

Hypophosphotemia

Allergic reaction

Neutrophil count decreased

Dyspepsia

Thrush

Hypercalcemia

Hyperglycemia

Hypocalcemia

Myalgia

Gastric obstruction

Insomnia

Malaise

Proteinuria

Allergic rhinitis

Dysgeusia

Dysphagia

Flatulence

Generalized muscle weakness

Non-cardiac chest pain

Oral pain

Peripheral neuropathy

Pleural effusion

Pruritus

Sinus tachycardia

Colitis

Death NOS

Abdominal distension

Anxiety

Arthralgia

Hyperhidrosis

Biliary tract infection

Gastroesophageal reflux disease (GERD)

Presyncope

Myocarditis

Biliary duct obstruction

Hyperkalemia

Syncope

Cardiac troponin increased

Duodenal obstruction

Lipase increased

Pleuritic pain

Edema limbs

Encephalopathy

Hypoxia

Ileal obstruction

Myocardial infarction

Sepsis

Ureteral obstruction

Urinary retention

Dry mouth

Dry skin

Sinus bradycardia

Sore throat

Bacteremia

Fungemia

Infusion related reaction

Meningitis

Peritoneal infection

Viral infection

100%

80%

60%

40%

20%

Study treatment Arm

Arm A (Atezolizumab)

Arm B (Atezolizumab, Cobimetinib)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Screening (biospecimen collection)Experimental Treatment1 Intervention

Patients undergo collection of blood and/or bone marrow samples at baseline, end of treatment cycle(s), and at relapse/refractory disease status (if applicable).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1730

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

LLS PedAL Initiative, LLCLead Sponsor

2 Previous Clinical Trials

98 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,923,683 Total Patients Enrolled

Children's Oncology GroupNETWORK

454 Previous Clinical Trials

236,980 Total Patients Enrolled

Media Library

Biospecimen Collection Clinical Trial Eligibility Overview. Trial Name: NCT04726241 — Phase 1 & 2

Acute Myeloid Leukemia Research Study Groups: Screening (biospecimen collection)

Acute Myeloid Leukemia Clinical Trial 2023: Biospecimen Collection Highlights & Side Effects. Trial Name: NCT04726241 — Phase 1 & 2

Biospecimen Collection 2023 Treatment Timeline for Medical Study. Trial Name: NCT04726241 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies for participants in this experimental research?

"According to the clinicaltrials.gov listing, this medical study is actively recruiting patients with a start date of November 30th 2021 and most recent edit on December 28th 2022."

Answered by AI

How many subjects are participating in this research endeavor?

"This clinical trial necessitates 960 suitable candidates to enrol. Participants may join from various sites, with Saint Peter's University Hospital in New Brunswick and Children’s Hospital of Philadelphia within Pennsylvania being two options."

Answered by AI

To what extent are hospitals involved in this trial's implementation?

"This clinical trial is currently recruiting 100 patients from locations such as Saint Peter's University Hospital in New Brunswick, Children's Hospital of Philadelphia in Philadelphia, and Providence Sacred Heart Medical Center and Children's Hospital in Spokane. Additionally there are other sites involved with this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study

Douglas Hawkins, MD 2022. "The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat - A Leukemia & Lymphoma Society and Children's Oncology Group Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04726241.

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