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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 3 trial • 218 Patients • NCT00557193

70%

Alanine aminotransferase increased

58%

Mucositis oral

57%

Aspartate aminotransferase increased

57%

Febrile neutropenia

53%

Infections and infestations - Other, specify

48%

Neutrophil count decreased

33%

Hypokalemia

25%

Diarrhea

23%

White blood cell decreased

22%

Catheter related infection

22%

Anorexia

15%

Fever

15%

Platelet count decreased

13%

Dehydration

12%

Upper respiratory infection

12%

Skin infection

12%

Urinary tract infection

Lung infection

Skin ulceration

Hypocalcemia

Hyponatremia

Alkaline phosphatase increased

Anemia

Weight loss

Hyperglycemia

Hypoglycemia

Hypoxia

Bronchial infection

Enterocolitis infectious

GGT increased

Hypoalbuminemia

Soft tissue infection

Lymphocyte count decreased

Skin and subcutaneous tissue disorders - Other, specify

Sepsis

Vomiting

Pain

Hypophosphatemia

Pain of skin

Oral pain

Anaphylaxis

Penile infection

Erythema multiforme

Blood and lymphatic system disorders - Other, specify

Cardiac disorders - Other, specify

Sinus tachycardia

Irritability

Scrotal infection

Small intestine infection

Fracture

Wound complication

Hyperkalemia

Hypertriglyceridemia

Generalized muscle weakness

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Penile pain

Pharyngeal mucositis

Pleural effusion

Stridor

Dry skin

Surgical and medical procedures - Other, specify

Hypotension

Acute kidney injury

Anal mucositis

Esophagitis

Gastritis

Nausea

Bladder infection

Wound infection

Investigations - Other, specify

Peripheral motor neuropathy

Peripheral sensory neuropathy

Epistaxis

Pneumonitis

Pulmonary edema

Respiratory failure

Hypertension

Enterocolitis

Acidosis

Renal and urinary disorders - Other, specify

100%

80%

60%

40%

20%

Study treatment Arm

Arm A (Standard Risk MLL-G)

Arm B (IR/HR MLL-R Chemotherapy)

Arm C (Efficacy/ Dose Level 2)

Induction (All Patients)

Post Induction (Follow-up Only)

Arm C (Safety/ Dose Level 1)

Arm C (Safety/ Dose Level 2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2020

0 / 8Eligibility criteria met