Study of Blood and Bone Marrow Samples in Patients With Chronic Myelogenous Leukemia Enrolled on a CALGB Clinical Trial

Active, not recruiting

• Conditions: Leukemia

• Registration Number: NCT01004640
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Studying samples of blood and bone marrow from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood and bone marrow samples in patients with chronic myelogenous leukemia enrolled on a CALGB clinical trial.

Detailed Description

OBJECTIVES:

* Monitor molecular response rates of patients receiving treatment for chronic myelogenous leukemia by quantitative reverse transcription polymerase chain reaction (RT-PCR) and quantitative Southern blot monitoring of blood samples.

* Compare quantitative RT-PCR and quantitative Southern blot results with marrow cytogenetics at the time of complete molecular response in these patients.

* Monitor the frequency of residual disease in patients who achieve a complete blood Southern blot and marrow cytogenetic response (eradication of BCR/ABL by Southern blot and absence of the Philadelphia chromosome by cytogenetics).

OUTLINE: Peripheral blood samples and bone marrow aspirates are collected at baseline and at 3, 6, and 9 months after starting therapy. If patient continues to receive protocol treatment after 9 months, additional peripheral blood samples are collected every 6 months and bone marrow aspirates are taken annually. In the event of disease progression (blast crisis), an additional peripheral blood sample and bone marrow aspirate are collected.

Samples are examined by quantitative Southern blot analysis with probes to BCR, quantitative reverse transcriptase-polymerase chain reaction analysis for BCR/ABL fusion transcripts, and cytogenetic analysis.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.

Study Timeline

• Study Start: 1998-12-15
• Primary Completion: 2001-02
• Study First Submitted: 2009-10-29
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of chronic myelogenous leukemia (CML)

• Concurrent enrollment on a CALGB treatment protocol for newly diagnosed or previously treated CML (e.g, CLB-19804)

  • Must not have initiated study therapy

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distribution response	Up to 1.5 years
Distribution of cytogenetic response	Up to 1.5 years
Frequency of residual disease in patients who have achieved a complete response	Up to 12 months
Distribution of RT-PCR response or Southern blot response	Up to 1.5 years

Trial Locations

Locations (160)

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

UCSF Medical Center-Mount Zion; 🇺🇸 San Francisco, California, United States

Beebe Medical Center; 🇺🇸 Lewes, Delaware, United States

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

Nanticoke Memorial Hospital; 🇺🇸 Seaford, Delaware, United States

Saint Francis Hospital - Wilmington; 🇺🇸 Wilmington, Delaware, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

Broward Health Medical Center; 🇺🇸 Fort Lauderdale, Florida, United States

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