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Clinical and Biological Predictors of Therapy-Related Leukemia

17 Years
Open (Enrolling)
Leukemia, Myelodysplastic Syndromes, Sarcoma

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Trial Information

Clinical and Biological Predictors of Therapy-Related Leukemia


- Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome
or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy
for sarcoma.

- Identify patients who are at increased risk of t-MDS/AML during or after therapy.

OUTLINE: Blood is collected from patients at diagnosis (preferably before chemotherapy or
transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after

Blood specimens are examined by clonality analysis (HUMARA), variant cell frequency
(glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras
mutation detection (single strand conformation polymorphism and sequencing of mutant

Patients do not receive the results of the genetic testing and the results do not influence
the type or duration of treatment.

PROJECTED ACCRUAL: A total of 321 patients will be accrued for this study within 4 years.

Inclusion Criteria


- Diagnosis of sarcoma including:

- Rhabdomyosarcoma

- Ewing's sarcoma

- Primitive neuroectodermal tumor

- Fibrosarcoma

- Malignant peripheral nerve sheath tumor

- Synovial cell sarcoma

- Osteosarcoma

- Other soft tissue sarcoma

- Must be currently receiving intensive or high-dose chemotherapy for sarcoma



- Children

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:


Principal Investigator

Stella M. Davies, MBBS, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Medical Center, Cincinnati


United States: Federal Government

Study ID:




Start Date:

December 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Sarcoma
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • localized osteosarcoma
  • metastatic osteosarcoma
  • childhood soft tissue sarcoma
  • nonmetastatic childhood soft tissue sarcoma
  • metastatic childhood soft tissue sarcoma
  • childhood fibrosarcoma
  • childhood synovial sarcoma
  • childhood neurofibrosarcoma
  • previously untreated childhood rhabdomyosarcoma
  • localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Rhabdomyosarcoma
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma



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