Official Title
Protocol For Genomically Profiling, Collecting, Archiving And Distributing Blood And Bone Marrow Specimens From Children And Young Adults With Hematologic Malignancy
Brief Title
Protocol For Genomically Profiling, Collecting, Archiving And Distributing Blood And Bone Marrow Specimens From Children And Young Adults With Hematologic Malignancy
Protocol ID
NCT04968834
Lead Sponsor
Dana-Farber Cancer Institute
Brief 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.
Detailed 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
Study Period
Enrollment Count
300 participants
Eligibility Criteria
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
Filters
Leukemia
Myelodysplastic Syndromes
Myeloproliferative Syndrome
RECRUITING
CHILD
ADULT