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NCT01139307 Clinical Trial

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

Leukemia Clinical Trial

Official title:
Development of Novel Therapeutics for AMKL

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01139307
Other study ID # AAML10B1
Secondary ID COG-AAML10B1CDR0
Status Completed
Phase N/A
First received June 5, 2010
Last updated February 19, 2016
Start date July 2009

Study information
Verified date February 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of acute megakaryoblastic leukemia

- Diagnosis of Down syndrome

- Cryopreserved specimens available

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

  • Leukemia
  • Leukemia, Megakaryoblastic, Acute

Intervention

Other:
• cell culture procedure

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Proliferation arrest No
Primary Polyploidization No
Primary Terminal differentiation No
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