An observational study in Leukemia, sponsored by Alliance for Clinical Trials in Oncology. Active, not recruiting at 161 sites in United States. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Alliance for Clinical Trials in Oncology · Observational
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.
OBJECTIVES:
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
PATIENTS ENTERED ONTO CALGB TREATMENT STUDIES FOR CML
Inclusion Criteria:
Concurrent enrollment on a CALGB treatment protocol for newly diagnosed or previously treated CML (e.g, CLB-19804)
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.
Genetic: DNA analysis · Genetic: Southern blotting · Genetic: cytogenetic analysis · Genetic: polymerase chain reaction
Correlative studies
Also known as: Laboratory Biomarker Analysis
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
Showing the first 100 of 161 sites.
This study is active, not recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology