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Biomarkers in Samples From Patients With Down Syndrome and Acute Megakaryoblastic Leukemia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01139307
First received: June 5, 2010
Last updated: February 19, 2016
Last verified: February 2016
  Purpose

RATIONALE: Studying samples of blood or tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from patients with Down syndrome and acute megakaryoblastic leukemia.


Condition Intervention
Leukemia
Other: cell culture procedure
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development of Novel Therapeutics for AMKL

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Proliferation arrest [ Designated as safety issue: No ]
  • Polyploidization [ Designated as safety issue: No ]
  • Terminal differentiation [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2009
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether megakaryocyte differentiation agents comprising a Rho kinase inhibitor and a JAK3 inhibitor can lead to proliferation arrest, polyploidization, and terminal differentiation of blasts in specimens from patients with Down syndrome and acute megakaryoblastic leukemia.

OUTLINE: Cryopreserved specimens are cultured and treated in vivo (in mice) and in vitro with megakaryocytic differentiation agents comprising a Rho kinase inhibitor and a JAK3 inhibitor.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of acute megakaryoblastic leukemia or diagnosis of Down syndrome when cryopreserved specimens are available.
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute megakaryoblastic leukemia
  • Diagnosis of Down syndrome
  • Cryopreserved specimens available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139307

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: John Crispino, PhD Robert H. Lurie Cancer Center
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01139307     History of Changes
Other Study ID Numbers: AAML10B1  COG-AAML10B1  CDR0000671427  NCI-2011-02218 
Study First Received: June 5, 2010
Last Updated: February 19, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
adult acute megakaryoblastic leukemia (M7)
childhood acute megakaryocytic leukemia (M7)
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies

Additional relevant MeSH terms:
Leukemia
Leukemia, Megakaryoblastic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid

ClinicalTrials.gov processed this record on September 26, 2016