Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia

Observational - NUP98/JARID1A as a Recurrent Aberration in Pediatric Acute Megakaryoblastic Leukemia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01642069

Enrollment

100

Registered

2012-07-17

Start date

2012-07-31

Completion date

2016-05-31

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Acute Megakaryocytic Leukemia (M7), Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

Brief summary

This laboratory study is looking into genes in samples from younger patients with acute megakaryoblastic leukemia (AMKL). Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and identify biomarkers related to cancer

Detailed description

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Cryopreserved mRNA Study Population Description: Samples from AAML0531 Sampling Method: Non-Probability Sample OBJECTIVES: I. To determine whether NUP98/JARID1A expression is a recurrent translocation in NUP98-rearranged cases in pediatric acute megakaryoblastic leukemia (AMKL). II. To screen the Children Oncology Group (COG) samples for genetic aberrations in pediatric AMKL. OUTLINE: Cryopreserved specimens are analyzed for NUP98 fusion to NSD1, JARID1A, and TOP1, myeloid/lymphoid or mixed-lineage leukemia (MLL)-rearrangements, and other gene expression profiling by reverse transcriptase polymerase chain reaction (RT-PCR) and karyotyping or fluorescence in situ hybridization (FISH). Results are then compared with each patient's outcome data.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 30 Years

Healthy volunteers

Inclusion criteria

* Cryopreserved specimens of pediatric patients diagnosed with acute megakaryoblastic leukemia

Design outcomes

Primary

Measure	Time frame
Complete remission (CR, defined as less than 5% blasts in the bone marrow, with regeneration of tri-lineage hematopoiesis, plus absence of leukemic cells in the cerebrospinal fluid or elsewhere)	Up to 8 weeks
Probability of event-free survival (pEFS, defined as time between diagnosis and first event, including non-remitting, death of any cause and second malignancy)	Up to 8 weeks
Overall survival (pOS, defined as time between diagnosis and death)	Up to 8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026