Acute Leukemia, Acute Lymphoblastic Leukemia, Multiple Myeloma, Myelodysplastic Syndrome
Conditions
Brief summary
Chromosomal analysis or the study of genetic differences in patients previously untreated with AML, ALL, MDS or MM may be helpful in the diagnosis and classification of disease. It may also improve the ability to predict the course of disease and the selection of therapy. Institutions must have either an Alliance-approved cytogeneticist or an agreement from an Alliance-approved main member cytogenetics laboratory to enroll a patient on CALGB 8461. The Alliance Approved Institutional Cytogeneticists list is posted on the Alliance for Clinical Trials in Oncology website.
Interventions
GENETICcytogenetic analysis
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients from adjuncts are eligible if the Main Member Cytogenetics laboratory has agreed to process samples from that adjunct. 2. Within one month of registration on CALGB 8461, register onto a CALGB treatment study for previously untreated AML, ALL, MDS, or MM patients. 3. Simultaneously with registration on CALGB 8461, register patients within the continental United States onto CALGB 9665 (LTB).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM | Up to 10 years |
| Correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters | Up to 10 years |
| Correlate specific karyotype groups with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens | Up to 10 years |
| Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols | Up to 10 years |
| To correlate specific karyotype groups with multidrug resistance data | Up to 10 years |
| To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history) | Up to 10 years |
| To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse on subsequent clinical course | up to 10 yeras |
| To identify new chromosome abnormalities important in leukemogenesis | Up to 10 years |
Countries
United States
Outcome results
None listed