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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003861
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 17, 2021
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
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.

Condition or disease Intervention/treatment
Leukemia Acute Lymphoblastic Leukemia Acute Promyelocytic Leukemia Other: laboratory biomarker analysis

Detailed Description:


  1. 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.
  2. 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.
  3. 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.
  4. 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.

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Study Type : Observational
Estimated Enrollment : 840 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Molecular Genetic Features of Acute Leukemia
Study Start Date : April 1999
Estimated Primary Completion Date : January 2100

Group/Cohort Intervention/treatment
Ancillary-Correlative (molecular genetic features)
Previously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry.
Other: laboratory biomarker analysis

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Tissue, Blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients enrolled on CALGB-19802, any CALGB treatment trial, SWOG-S0521, or SWOG-S0535
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003861

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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
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Study Chair: Wendy Stock, MD University of Chicago
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Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00003861    
Other Study ID Numbers: CALGB-9862
U10CA076001 ( U.S. NIH Grant/Contract )
CDR0000067025 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Myeloid, Acute
Leukemia, Myeloid