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Active, not recruitingNCT00003861Updated Aug 31, 2023

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

An observational study in Leukemia, Acute Lymphoblastic Leukemia and Acute Promyelocytic Leukemia, sponsored by Alliance for Clinical Trials in Oncology. Active, not recruiting at 51 sites in United States. Per ClinicalTrials.gov, last updated 2023-08-31.

Sponsored by Alliance for Clinical Trials in Oncology · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
840
Sex
All
01

Study 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.

Read the detailed description

Objectives:

  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.
02

Conditions studied

  • Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Promyelocytic Leukemia
03

In context

Leukemia

5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.

This study's planned enrollment of 840 is above the median of 120 across 747 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Browse Alliance for Clinical Trials in Oncology studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Eligibility criteria

  • 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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
840 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Ancillary-Correlative (molecular genetic features)

    Previously collected blood and tissue samples are analyzed via RT-PCR and flow cytometry.

    Other: laboratory biomarker analysis

Interventions

  • Otherlaboratory biomarker analysis
06

What researchers measure

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

07

Study locations

51 sites
  • Naval Medical Center - San Diego
    San Diego, California 92134, United States
  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California 94115, United States
  • Tunnell Cancer Center at Beebe Medical Center
    Lewes, Delaware 19958, United States
  • CCOP - Christiana Care Health Services
    Newark, Delaware 19713, United States
  • Florida Hospital Cancer Institute at Florida Hospital Orlando
    Orlando, Florida 32803-1273, United States
  • University of Illinois Cancer Center
    Chicago, Illinois 60612-7243, United States
  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637-1470, United States
  • Holden Comprehensive Cancer Center at University of Iowa
    Iowa City, Iowa 52242-1002, United States
  • Harold Alfond Center for Cancer Care
    Augusta, Maine 04330, United States
  • CancerCare of Maine at Eastern Maine Medical Center
    Bangor, Maine 04401, United States
  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough
    Scarborough, Maine 04074, United States
  • Greenebaum Cancer Center at University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Union Hospital of Cecil County
    Elkton, Maryland 21921, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Dana-Farber/Brigham and Women's Cancer Center
    Boston, Massachusetts 02115, United States
  • Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
    Boston, Massachusetts 02115, United States
  • Masonic Cancer Center at University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
    Columbia, Missouri 65203, United States
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    St Louis, Missouri 63110, United States
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada 89102, United States
  • CCOP - Nevada Cancer Research Foundation
    Las Vegas, Nevada 89106, United States
  • Cancer Institute of New Jersey at Cooper - Voorhees
    Voorhees Township, New Jersey 08043, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263-0001, United States
  • CCOP - Hematology-Oncology Associates of Central New York
    East Syracuse, New York 13057, United States
  • Queens Cancer Center of Queens Hospital
    Jamaica, New York 11432, United States
  • Monter Cancer Center of the North Shore-LIJ Health System
    Lake Success, New York 11042, United States
  • CCOP - North Shore University Hospital
    Manhasset, New York 11030, United States
  • Don Monti Comprehensive Cancer Center at North Shore University Hospital
    Manhasset, New York 11030, United States
  • Long Island Jewish Medical Center
    New Hyde Park, New York 11040, United States
  • New York Weill Cornell Cancer Center at Cornell University
    New York, New York 10021, United States
  • Mount Sinai Medical Center
    New York, New York 10029, United States
  • SUNY Upstate Medical University Hospital
    Syracuse, New York 13210, United States
  • Veterans Affairs Medical Center - Syracuse
    Syracuse, New York 13210, United States
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    Chapel Hill, North Carolina 27599-7295, United States
  • Duke Cancer Institute
    Durham, North Carolina 27710, United States
  • Wayne Memorial Hospital, Incorporated
    Goldsboro, North Carolina 27534, United States
  • Leo W. Jenkins Cancer Center at ECU Medical School
    Greenville, North Carolina 27834, United States
  • Kinston Medical Specialists
    Kinston, North Carolina 28501, United States
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1096, United States
  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210-1240, United States
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    Pittsburgh, Pennsylvania 15224-1791, United States
  • Rhode Island Hospital Comprehensive Cancer Center
    Providence, Rhode Island 02903, United States
  • Miriam Hospital
    Providence, Rhode Island 02906, United States
  • Cancer Centers of the Carolinas - Faris Road
    Greenville, South Carolina 29605, United States
  • Cancer Centers of the Carolinas - Grove Commons
    Greenville, South Carolina 29605, United States
  • Greenville Hospital Cancer Center
    Greenville, South Carolina 29605, United States
  • CCOP - Greenville
    Greenville, South Carolina 29615, United States
  • Cancer Centers of the Carolinas - Greer Medical Oncology
    Greer, South Carolina 29650, United States
  • Cancer Centers of the Carolinas - Seneca
    Seneca, South Carolina 29672, United States
  • Cancer Centers of the Carolinas - Spartanburg
    Spartanburg, South Carolina 29307, United States
  • Virginia Commonwealth University Massey Cancer Center
    Richmond, Virginia 23298-0037, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 1999 and a primary completion of Jan 2100. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 1999
First posted
Jan 27, 2003
Start
Apr 1999
Primary completionEst.
Jan 2100
Last update
Aug 31, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00003861
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Apr 1999
Primary completion
Jan 2100 (estimated)
Last update
Aug 31, 2023

Study contacts

Wendy Stock, MD
study chair · University of Chicago
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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