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Rapid Profiling of Bone Marrow, at Presentation and After 5 Days of Induction Therapy

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ClinicalTrials.gov Identifier: NCT01268800
Recruitment Status : Unknown
Verified May 2014 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : December 31, 2010
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Personalization of AML therapy, require a reliable mechanism for accurate characterization of patient specific leukemia phenotype and genotype. Patient's specific leukemic phenotype or in practical clinical term, patient's leukemia sensitivity to induction therapy, should best investigated in-vivo during induction. Elimination of circulating leukemic blasts from peripheral blood by day 5 was shown to discriminate between good responders with superior long term survival and poor responders with poor outcome. However, many AML patients have no circulating blasts at diagnosis and even in those who have, elimination rate of it from peripheral blood was never correlated with actual response in bone marrow.

Currently, the only available source for patient's specific leukemia profile, is the bone marrow sample at diagnosis. Since leukemic blasts are heterogeneous and come from multiple different clones, "on diagnosis" marrow consist a spectrum of chemotherapy sensitive and resistance clones. Clones may vary by their molecular abnormalities and results from "on diagnosis" marrow may overlook minor resistant but existing clones. Long term prognosis is determined by those resistant clones and though our interests should be focused into the abnormalities of these clones. Residual blasts on day 5 marrow may better represent the profile of patient's leukemic resistant clones.


Condition or disease
AML

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rapid Profiling of Bone Marrow, at Presentation and After 5 Days of Induction Therapy, a Sensitive Method for Identifying Resistant AML Clones
Study Start Date : February 2011
Estimated Primary Completion Date : August 2014
Groups and Cohorts

Group/Cohort
AML induction
Adults AML patients who were referred for intensive induction therapy


Outcome Measures

Primary Outcome Measures :
  1. complete remission [ Time Frame: 30-54 days ]
    Bone marrow blasts <5% upon recovery from induction therapy


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: two years ]
  2. relapse rate [ Time Frame: two years ]

Biospecimen Retention:   Samples With DNA
Blood bone marrow and buccal smear

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults (>18) AML patients
Criteria

Inclusion Criteria:

  • Diagnosis of acute myeloid leukemia other than APL
  • Age > 18
  • Patient's considered by their physician "fit" for intensive induction therapy

Exclusion Criteria:

  • Withdrawal of informed consent or inability to consent
  • Previous allogeneic transplantation.
  • One of the following lab values persistent from presentation to day 5:

    • Serum creatinine > 2mg/dl, Direct bilirubin > 2mg/dl
    • SGOT (AST) > x4 upper limit of normal
    • Left ventricular ejection fraction < 40% as assessed 2-D echocardiogram
    • Coagulation abnormalities (INR > 1.6, PTT > x1.5 normal range)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268800


Contacts
Contact: Yishai ofran, MD 972-4-5842541 y_ofran@rambam.health.gov.il

Locations
Israel
Rambam medical center Recruiting
Haifa, Israel, 31096
Contact: Yishai Ofran, MD    972-4-8542541    y_ofran@rambam.health.gov.il   
Principal Investigator: Yishai Ofran, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Yishai Ofran, MD Rambam Health Care Campus
More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01268800     History of Changes
Other Study ID Numbers: 0588-10-rmb-CTIL
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Rambam Health Care Campus:
AML
Induction