Collection of Blood and Bone Marrow Samples From Select Patients With CML to Measure Minimal Residual Disease

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00819143
First received: January 7, 2009
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

Although allogeneic stem cell transplantation is curative in CML, evidence of the BCR-ABL oncogene at low levels is still found in long-term follow-up of survivors. Such low levels of BCR-ABL post-transplant which do not fulfill criteria for molecular relapse are monitored regularly and considered to be suppressed by the GVL effect. Treatment with donor lymphocyte infusions is only instituted when quantifiable BCR-ABL transcript levels rise steadily, indicative of a true molecular relapse .

Similarly, BCR-ABL is still detectable in the majority of CML patients treated with imatinib who achieve complete cytogenetic response, although the amount of BCR-ABL transcripts seem to decline with longer follow-up. With 5 years follow-up of CML patients at CP who received imatinib, the estimated cumulative best rates of complete hematologic response and complete cytogenetic response were 98 percent and 87 percent, respectively10. For the minority of CP-CML patients who do not respond satisfactorily to imatinib, second-generation tyrosine kinase inhibitors are now the recommended next line of treatment.

A major question facing clinicians is whether imatinib and the other more pharmacologically potent second-generation tyrosine kinase inhibitors;can suppress the CML clone at the leukemic stem cell level as effectively as allogeneic stem cell transplantation. This protocol is designed to scientifically compare the treatment responses of patients who are treated with allogeneic stem cell transplantation with patients who receive imatinib or second generation tyrosine kinase inhibitors.

The primary endpoint of this trial will be the proportion of patients who have detected minimal residual disease (DMRD) in primitive CD34 plus progenitor subpopulations no earlier than 60 days from the onset of their respective treatments.


Condition
Leukemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collection of Blood and Bone Marrow Samples From Select Patients With CML to Measure Minimal Residual Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 3
Study Start Date: December 2008
Estimated Study Completion Date: July 2011
Detailed Description:

Although allogeneic stem cell transplantation is curative in CML, evidence of the BCR-ABL oncogene at low levels is still found in long-term follow-up of survivors. Such low levels of BCR-ABL post-transplant, which do not fulfill criteria for molecular relapse are monitored regularly and considered to be suppressed by the GVL effect. Treatment with donor lymphocyte infusions is only instituted when quantifiable BCR-ABL transcript levels rise steadily, indicative of a true molecular relapse."

Similarly, BCR-ABL is still detectable in the majority of CML patients treated with imatinib who achieve complete cytogenetic response, although the amount of BCR-ABL transcripts seem to decline with longer follow-up. With 5 years follow-up of CML patients at CP who received imatinib, the estimated cumulative best rates of complete hematologic response and complete cytogenetic response were 98 percent and 87 percent, respectively 10. For the minority of CP-CML patients who do not respond satisfactorily to imatinib, second-generation tyrosine kinase inhibitors are now the recommended next line of treatment.

A major question facing clinicians is whether imatinib and the other more pharmacologically potent second-generation tyrosine kinase inhibitors can suppress the CML clone at the leukemic stem cell level as effectively as allogeneic stem cell transplantation. This protocol is designed to scientifically compare the treatment responses of patients who are treated with allogeneic stem cell transplantation with patients who receive imatinib or second generation tyrosine kinase inhibitors.

The primary endpoint of this trial will be the proportion of patients who have detected minimal residual disease (DMRD) in primitive CD34 plus progenitor subpopulations no earlier than 60 days from the onset of their respective treatments.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Diagnosed with CML
    2. Age 18 years and older

EXCLUSION CRITERIA:

  1. Less than 60 days from onset of CML directed treatment
  2. Unable to comprehend the investigational nature of the protocol participation or unable to sign their own consent document.
  3. Platelet count less than 50 times 10(9)/L (Bone marrow donors only)
  4. Pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819143

Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00819143     History of Changes
Other Study ID Numbers: 090062, 09-H-0062
Study First Received: January 7, 2009
Last Updated: July 14, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Tissue Procurement
Sample Collection
Chronic Myelogenous Leukemia
Laboratory Research

Additional relevant MeSH terms:
Leukemia
Neoplasm, Residual
Neoplasms
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014