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S0106B, Stem Cell Origin in AML: Prognostic and Therapeutic Implications


N/A
18 Years
N/A
Not Enrolling
Female
Leukemia

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Trial Information

S0106B, Stem Cell Origin in AML: Prognostic and Therapeutic Implications


OBJECTIVES:

- Estimate the proportion of acute myeloid leukemia (AMLs) that originate in CD33+
precursors or in which uncontrolled growth is limited to CD33+ precursors.

- Explore whether there is an association between the cellular origin of AML (i.e.,
origination in CD33+ precursors or not) and cytogenetic, molecular, and other patient
characteristics.

- Explore whether overall survival (OS), event-free survival (EFS), disease-free survival
(DFS), response rate (RR), or relapse rate is improved for patients with AMLs that
originate in CD33+ precursors or in which uncontrolled growth is limited to CD33+
precursors compared to patients with clonally involved cells not detected.

OUTLINE: Archived bone marrow samples are analyzed for CD33+ progenitors, X-chromosome
inactivation, and somatic mutations (t(8;21), inv(16), FLT3/ITD, NPM1, CEBPA, KIT) by
fluorescence-activated cell sorting, long-term culture in hypoxic condition in
cytokine-containing liquid media, and flow cytometry. Results are then compared with each
patient clinical data.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnostic bone marrow specimens from female patients with untreated AML undergoing
intensive ("3+7"-like) induction chemotherapy

- Specimens from the South Western Oncology Group (SWOG) protocols S0106 (age 18 to 60
years), excluding patients who received gemtuzumab ozogamicin (GO), and S9333 (age >
60 years)

PATIENT CHARACTERISTICS:

- See Disease Characteristics

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

Time Perspective: Retrospective

Outcome Measure:

Association between CD33+ precursors and cytogenetic and/or molecular risks using Fisher's exact test

Outcome Time Frame:

May 2012

Safety Issue:

No

Principal Investigator

Roland Walter, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000730121

NCT ID:

NCT01575535

Start Date:

April 2012

Completion Date:

May 2012

Related Keywords:

  • Leukemia
  • untreated adult acute myeloid leukemia
  • adult acute basophilic leukemia
  • adult acute eosinophilic leukemia
  • adult erythroleukemia (M6a)
  • adult pure erythroid leukemia (M6b)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute monoblastic leukemia (M5a)
  • adult acute monocytic leukemia (M5b)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myeloblastic leukemia without maturation (M1)
  • 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)
  • adult acute myelomonocytic leukemia (M4)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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