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

NCT01407757 | Completed

• 3 other identifiers: AAML11B10COG-AAML11B10NCI-2011-03802
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Genetic changes in CD33 impact outcome of gemtuzumab ozogamicin-based therapy

Interventions

DNA analysis GENETIC

gene expression analysis GENETIC

laboratory biomarker analysis OTHER

pharmacogenomic studies OTHER

Eligibility Criteria

• Age: Up to 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed with acute myeloid leukemia.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Related Publications (3)

• Pollard JA, Guest E, Alonzo TA, Gerbing RB, Loken MR, Brodersen LE, Kolb EA, Aplenc R, Meshinchi S, Raimondi SC, Hirsch B, Gamis AS. Gemtuzumab Ozogamicin Improves Event-Free Survival and Reduces Relapse in Pediatric KMT2A-Rearranged AML: Results From the Phase III Children's Oncology Group Trial AAML0531. J Clin Oncol. 2021 Oct 1;39(28):3149-3160. doi: 10.1200/JCO.20.03048. Epub 2021 May 28.

  PMID: 34048275 DERIVED

• Tarlock K, Alonzo TA, Wang YC, Gerbing RB, Ries R, Loken MR, Pardo L, Hylkema T, Joaquin J, Sarukkai L, Raimondi SC, Hirsch B, Sung L, Aplenc R, Bernstein I, Gamis AS, Meshinchi S, Pollard JA. Functional Properties of KIT Mutations Are Associated with Differential Clinical Outcomes and Response to Targeted Therapeutics in CBF Acute Myeloid Leukemia. Clin Cancer Res. 2019 Aug 15;25(16):5038-5048. doi: 10.1158/1078-0432.CCR-18-1897. Epub 2019 Jun 10.

  PMID: 31182436 DERIVED

• Vujkovic M, Attiyeh EF, Ries RE, Goodman EK, Ding Y, Kavcic M, Alonzo TA, Wang YC, Gerbing RB, Sung L, Hirsch B, Raimondi S, Gamis AS, Meshinchi S, Aplenc R. Genomic architecture and treatment outcome in pediatric acute myeloid leukemia: a Children's Oncology Group report. Blood. 2017 Jun 8;129(23):3051-3058. doi: 10.1182/blood-2017-03-772384. Epub 2017 Apr 14.

  PMID: 28411282 DERIVED

MeSH Terms

Conditions

Leukemia; Congenital Abnormalities; Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute

Interventions

Gene Expression Profiling; Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Jatinder Lamba, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2011
• First Posted: August 2, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2016
• Last Updated: May 19, 2016

Record last verified: 2016-05