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OpenTrials
Active, Not Recruiting

NCT Number: NCT00003861

Diagnostic Study of Patients With Acute Lymphoblastic Leukemia or Acute Promyelocytic Leukemia

This research trial studies molecular genetic features in blood and tissue samples from patients with newly diagnosed acute lymphoblastic leukemia or acute promyelocytic leukemia. Studying samples of blood and tissue from patients with acute lymphoblastic leukemia or acute promyelocytic leukemia in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Leukemia Acute Lymphoblastic Leukemia Acute Promyelocytic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Promyelocytic, Acute Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Naval Medical Center - San Diego, San Diego, California, United States

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About this study

Objectives:

  • To perform quantitative PCR using known leukemia specific markers in diagnostic bone marrow specimens of patients with newly diagnosed APL and ALL and to correlative pre-treatment copy number with other biologic and molecular features, clinical response, and treatment outcome.
  • To evaluate the expression of novel genes or microRNAs implicated in disease pathogenesis and treatment response in pretreatment blood and bone marrow specimens of patients with APL and ALL and to correlate expression level with other biological features and treatment outcome.
  • To evaluate the clinical significance of sequential quantitative MRD measurements using real-time quantitative PCR and/or flow cytometry during and following treatment of ALL and APL and correlate these findings with efficacy of novel treatment approaches and with other biological and clinical prognostic features.
  • To compare measurement of MRD in blood with bone marrow specimens in sequential remission specimens of patients receiving treatment on ALL and APL treatment trials.

Who can participate

Healthy volunteers accepted: No

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

  • Patients with a diagnosis of acute lymphoblastic leukemia (ALL) entered onto CALGB treatment trials for previously untreated ALL must be enrolled on CALGB 9862. Entry on CALGB 8461 is strongly encouraged.
  • Patients with a diagnosis of acute promyelocytic leukemia (APL) enrolled on SWOG S0521 or S0535 must be enrolled on CALGB 9862.

Treatment and study plan

laboratory biomarker analysis

Other

Primary outcomes

  1. Disease-free survival

    Time frame: At baseline

  2. Overall survival

    Time frame: At baseline

  3. Association of novel genes or micorRNAs with other biomarkers

    Time frame: At baseline

Secondary outcomes

  1. Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL

    Time frame: At baseline

  2. Clinical significance of MRD as defined by W T-1

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Molecular Genetic Features of Acute Leukemia

Important dates

Study start
1999
Primary completion
2100
First posted
Jan 27, 2003
Registry last updated
Aug 31, 2023

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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