Home/Get Matched/NCT04726241
Phase 1Recruiting
View on ClinicalTrials.gov

Testing Biospecimen Collection for acute lymphoblastic leukemia

Official title: 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

Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

Condition: Acute Lymphoblastic LeukemiaSponsor: PedAL BCU, LLCTarget enrollment: 960
  • Phase 1
  • 1 group
  • Sites in Québec, Calgary and 9 more cities
  • Recruiting
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL), QuébecAlberta Children's Hospital, Calgary, AlbertaUniversity of Alberta Hospital, Edmonton, AlbertaBritish Columbia Children's Hospital, Vancouver, British ColumbiaCancerCare Manitoba, Winnipeg, ManitobaIWK Health Centre, Halifax, Nova ScotiaChildren's Hospital, London, OntarioChildren's Hospital of Eastern Ontario, Ottawa, OntarioHospital for Sick Children, Toronto, OntarioThe Montreal Children's Hospital of the MUHC, Montreal, QuebecCentre Hospitalier Universitaire Sainte-Justine, Montreal, QuebecCentre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke, Quebec

Interventions

  • Medical procedure

    Biospecimen Collection

    Undergo collection of blood and/or bone marrow samples

Canadian Sites (12)

12 of 12 recruiting

  • Alberta Children's Hospital

    Calgary, Alberta

    Recruiting
  • University of Alberta Hospital

    Edmonton, Alberta

    Recruiting
  • British Columbia Children's Hospital

    Vancouver, British Columbia

    Recruiting

Eligibility Criteria

See who this study is looking for17 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  • +Patients must be less than 22 years of age at the time of study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
  • +Patient must have one of the following at the time of study enrollment:
  • +Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in protocolProtocolThe detailed plan a study must follow.Read more →
  • +This includes isolated myeloid sarcoma
  • +Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)
  • +Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria:
  • +Second or greater B-ALL medullary relapse, excluding KMT2Ar
  • +Any first or greater B-ALL medullary relapse involving KMT2Ar
  • +Any first or greater T-ALL medullary relapse with or without KMT2Ar
  • +Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol
  • +Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML)
  • +Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)
  • +Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
  • +Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)
  • +Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
  • +All patients and/or their parents or legal guardians must sign a written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to detect a condition before symptoms appear.

Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

Everyone in this study is in one group and receives Biospecimen Collection.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

There is only one group in this study, so there is no assignment to different treatments.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a maximum age of 22 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 960 people.

The study is currently expected to finish around December 2030.

The main measurement is taken over: Up to 5 years.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial — measured over Up to 5 years.

Maintain a longitudinal and comprehensive registry, as well as specimen bank of children and young adults with acute leukemias — measured over Up to 5 years.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT04726241 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Biospecimen CollectionProcedure

Undergo collection of blood and/or bone marrow samples

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

There is only one group in this study, so there is no assignment to different treatments.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Up to 5 years.

The study as a whole is currently expected to finish around 2030-12-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 960 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 32 locations, including: Québec, Canada; Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada, and 26 more.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.

Other Sites (25)

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Michigan State University

East Lansing, Michigan, United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Corewell Health Children's

Royal Oak, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Albany Medical Center

Albany, New York, United States

Maimonides Medical Center

Brooklyn, New York, United States

NYU Langone Hospital - Long Island

Mineola, New York, United States

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

State University of New York Upstate Medical University

Syracuse, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

And 5 more sites worldwide.

Think this trial might be right for you?

Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.

See if this trial could fit you

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.