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Active, Not Recruiting

NCT Number: NCT00048958

Cytogenetic Studies in Acute Leukemia and Multiple Myeloma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Leukemia Acute Lymphoblastic Leukemia Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Precursor Cell Lymphoblastic Leukemia-Lymphoma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Patients from adjuncts are eligible if the Main Member Cytogenetics laboratory has agreed to process samples from that adjunct.
  • Within one month of registration on CALGB 8461, register onto a CALGB treatment study for previously untreated AML, ALL, MDS, or MM patients.
  • Simultaneously with registration on CALGB 8461, register patients within the continental United States onto CALGB 9665 (LTB).

Treatment and study plan

cytogenetic analysis

Genetic

Primary outcomes

  1. Determine the incidence of specific less common primary as well as common secondary chromosome abnormalities in adult AML, ALL, MDS and MM

    Time frame: Up to 10 years

  2. Correlate specific (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters

    Time frame: Up to 10 years

  3. Correlate specific karyotype groups with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens

    Time frame: Up to 10 years

  4. Correlate specific karyotype groups with selected molecular abnormalities as studied in CALGB leukemia protocols

    Time frame: Up to 10 years

  5. To correlate specific karyotype groups with multidrug resistance data

    Time frame: Up to 10 years

  6. To correlate specific karyotype groups with epidemiologic data (toxic exposure and family history)

    Time frame: Up to 10 years

  7. 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

    Time frame: up to 10 yeras

  8. To identify new chromosome abnormalities important in leukemogenesis

    Time frame: Up to 10 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Cytogenetic Studies in Acute Leukemia and Multiple Myeloma: Companion to CALGB Treatment Studies For Previously Untreated Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS) or Multiple Myeloma (MM) Patients

Important dates

Study start
1984
Primary completion
2100
First posted
Jan 27, 2003
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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