Studying Genes in Samples From Younger Patients With Acute Megakaryoblastic Leukemia
|ClinicalTrials.gov Identifier: NCT01642069|
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : May 18, 2016
|Condition or disease||Intervention/treatment|
|Childhood Acute Megakaryocytic Leukemia (M7) Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies||Other: laboratory biomarker analysis|
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
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.
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 Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Observational - NUP98/JARID1A as a Recurrent Aberration in Pediatric Acute Megakaryoblastic Leukemia|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
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.
Other: laboratory biomarker analysis
- 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) [ Time Frame: 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) [ Time Frame: Up to 8 weeks ]
- Overall survival (pOS, defined as time between diagnosis and death) [ Time Frame: Up to 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642069
|United States, California|
|Children's Oncology Group|
|Monrovia, California, United States, 91006-3776|
|Principal Investigator:||Soheil Meshinchi, MD||Children's Oncology Group|