Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia

Completed

• Conditions: Childhood Acute Megakaryocytic Leukemia (M7); Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01642069
• Lead Sponsor: Children's Oncology Group

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-15
• Study First Submitted QC: 2012-07-15
• Study First Posted: 2012-07-17
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Cryopreserved specimens of pediatric patients diagnosed with acute megakaryoblastic leukemia

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	laboratory biomarker analysis	Cryopreserved specimens are analyzed for NUP98 fusion to NSD1, JARID1A, and TOP1, myeloid/lymphoid or MLL-rearrangements, and other gene expression profiling by RT-PCR and karyotyping or FISH. Results are then compared with each patient's outcome data.

Primary Outcome Measures

Name	Time	Method
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
Overall survival (pOS, defined as time between diagnosis and death)	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

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States