Overview

This trial is active, not recruiting.

Condition leukemia
Treatments dna analysis, southern blotting, cytogenetic analysis, polymerase chain reaction
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date December 1998
End date February 2001
Trial size 60 participants
Trial identifier NCT01004640, CALGB-29801, CDR0000078595, U10CA031946, U10CA180821

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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.
dna analysis
southern blotting
cytogenetic analysis Laboratory Biomarker Analysis
Correlative studies
polymerase chain reaction

Primary Outcomes

Measure
Distribution response
time frame: Up to 1.5 years
Distribution of cytogenetic response
time frame: Up to 1.5 years
Distribution of RT-PCR response or Southern blot response
time frame: Up to 1.5 years
Frequency of residual disease in patients who have achieved a complete response
time frame: Up to 12 months

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Molecular and Cytogenetic Monitoring of CML - A Mandatory Companion to CALGB 19804
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.