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Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01407757
First received: July 30, 2011
Last updated: August 6, 2011
Last verified: August 2011
History of Changes
  Purpose

RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well patients will respond to treatment. It may also help doctors learn more about how gemtuzumab ozogamicin works in the body.

PURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from patients with acute myeloid leukemia treated on COG-AAML0531.


Condition Intervention
Leukemia
 Genetic: DNA analysis
Genetic: gene expression analysis
Other: laboratory biomarker analysis
Other: pharmacogenomic studies

Study Type: Observational
Official Title: Pharmacogenetics of Gemtuzumab Ozogamicin (GO) Therapy in Acute Myeloid Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Genetic changes in CD33 impact outcome of gemtuzumab ozogamicin-based therapy [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: July 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To genotype the genomic DNA from acute myeloid leukemia (AML) patients treated on COG-AAML0531 clinical trial for CD33 (and PgP and SOC3) single nucleotide polymorphisms (SNPs).

OUTLINE: Archived DNA samples are analyzed for single nucleotide polymorphisms in CD33, PgP, and SOC3 genes by Sequenome platform. Results are then compared with patients clinical outcomes, including minimal-residual disease levels post induction I (chemotherapy and gemtuzumab ozogamicin), complete remission rates, refractory disease with various levels of bone marrow blasts, development of CNS/persistent disease, event-free survival, overall survival, and toxicity.

  Eligibility

Ages Eligible for Study:   up to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed with acute myeloid leukemia
  • DNA samples from patients treated on COG-AAML0531

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407757

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jatinder Lamba, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01407757     History of Changes
Other Study ID Numbers: CDR0000706823, COG-AAML11B10
Study First Received: July 30, 2011
Last Updated: August 6, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
adult acute basophilic leukemia
childhood acute basophilic leukemia
adult acute eosinophilic leukemia
childhood acute eosinophilic leukemia
adult acute myeloblastic leukemia without maturation (M1)
childhood acute myeloblastic leukemia without maturation (M1)
adult acute minimally differentiated myeloid leukemia (M0)
childhood acute minimally differentiated myeloid leukemia (M0)
 adult acute myeloblastic leukemia with maturation (M2)
childhood acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
childhood acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
childhood acute monoblastic leukemia (M5a)
childhood acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
childhood acute erythroleukemia (M6)
adult acute megakaryoblastic leukemia (M7)
childhood acute megakaryocytic leukemia (M7)
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
 Gemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013