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

Active, not recruiting

• Conditions: Leukemia; Acute Lymphoblastic Leukemia; Acute Promyelocytic Leukemia

• Registration Number: NCT00003861
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 1999-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31
• Primary Completion: 2100-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival	At baseline
Overall survival	At baseline
Association of novel genes or micorRNAs with other biomarkers	At baseline

Secondary Outcome Measures

Name	Time	Method
Clinical significance of MRD as defined by W T-1	At baseline
Clinical significance of minimal residual disease (MRD) as defined by BCR-ABL	At baseline

Trial Locations

Locations (51)

Naval Medical Center - San Diego; 🇺🇸 San Diego, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Tunnell Cancer Center at Beebe Medical Center; 🇺🇸 Lewes, Delaware, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando; 🇺🇸 Orlando, Florida, United States

University of Illinois Cancer Center; 🇺🇸 Chicago, Illinois, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Holden Comprehensive Cancer Center at University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Harold Alfond Center for Cancer Care; 🇺🇸 Augusta, Maine, United States

CancerCare of Maine at Eastern Maine Medical Center; 🇺🇸 Bangor, Maine, United States

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