NCT01004640

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

Molecular and Cytogenetic Monitoring of CML - A Mandatory Companion to CALGB 19804

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
GENETIC	DNA analysis
GENETIC	Southern blotting
GENETIC	cytogenetic analysis	Correlative studies
GENETIC	polymerase chain reaction

Timeline

• Start date: 1998-12-15
• Primary completion: 2001-02-01
• First posted: 2009-10-30
• Last updated: 2023-09-14

Locations

161 sites across 1 country: United States