Protocol For Genomically Profiling Collecting Archiving And Distributing Blood And Bone Marrow Specimens From Children And Young Adults With Hematologic Malignancy

  • STATUS
    Recruiting
  • End date
    Jun 26, 2025
  • participants needed
    300
  • sponsor
    Dana-Farber Cancer Institute
Updated on 26 July 2021
hematologic malignancy
acute leukemia
leukemia
chronic leukemia

Summary

This research study is a genomic profiling and repository study for children and young adults who have leukemia, myelodysplastic syndrome (MDS) or myeloproliferative syndrome (MPS). Genes are the part of cells that contain the instructions which tell cells how to make the right proteins to grow and work. Genes are composed of DNA letters that spell out these instructions. Genomic profiling helps investigators understand why the disease develops and the instructions that led to its development. Understanding the genetic factors of the disease can also help investigator understand why the disease of some people can respond to certain therapies differently than others.

The genomic profiling will be performed using bone marrow and blood samples that either have already been obtained during a previous clinical procedure or will be obtained at the time of a scheduled clinical procedure. Studying the genetic information in the cells of these samples will provide information about the origin, progression, and treatment of leukemia and myeloproliferative syndromes and myelodysplastic syndrome. Storing the bone marrow and blood samples will allow for additional research and genomic assessments to be performed in the future.

Description

Pediatric patients with new diagnosis or relapsed/refractory acute leukemia, MDS/AML, chronic leukemia, myeloproliferative syndromes or myelodysplastic syndrome will be enrolled onto this study. At the time of enrollment, a sample of the leukemia will be submitted for genomic profiling using CLIA assay(s). This information will be returned to the treating oncologist. The study will collect follow up data on patient outcome and whether the genomic profiling influenced treatment.

It is expected that about 100 people each year will take part in this research study at 8 medical centers in the United States

Details
Condition Bone marrow disorder, Preleukemia, leukemia, MYELODYSPLASTIC SYNDROME, Myeloproliferative Syndromes, Myeloproliferative Syndrome, myelodysplastic syndromes, leukemias, myelodysplastic syndrome (mds)
Treatment Genomic profiling
Clinical Study IdentifierNCT04968834
SponsorDana-Farber Cancer Institute
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: birth to < 30 years of age
Diagnosis
\-- Patient with acute leukemia, chronic leukemia, MDS/AML, myelodysplastic
syndrome or myeloproliferative syndromes. Disease can be newly diagnosed or
relapsed/refractory
Pathology Criteria
\-- Histologic confirmation of leukemia or myelodysplastic syndrome (MDS) or
myeloproliferative syndrome (MPS) at the time of diagnosis or recurrence
Specimen Criteria
Sufficient sample available for genomic profiling OR bone marrow aspirate/blood draw planned for clinical care which is anticipated to allow collection of minimum specimen for testing (See Section 6.1 for description of specimen requirements)

Exclusion Criteria

Insufficient leukemia or MDS specimen available for profiling from diagnosis or recurrence (See Section 6.1); or bone marrow evaluations NOT planned for clinical care; or peripheral blast percentage <20%, or clinical blood draw not planned
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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