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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01268800
First received: December 30, 2010
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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
AML

Study Type: Observational
Study Design: 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

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • complete remission [ Time Frame: 30-54 days ] [ Designated as safety issue: No ]
    Bone marrow blasts <5% upon recovery from induction therapy


Secondary Outcome Measures:
  • Overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]
  • relapse rate [ Time Frame: two years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood bone marrow and buccal smear


Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
AML induction
Adults AML patients who were referred for intensive induction therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01268800     History of Changes
Other Study ID Numbers: 0588-10-rmb-CTIL
Study First Received: December 30, 2010
Last Updated: May 5, 2014
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
AML
Induction

ClinicalTrials.gov processed this record on September 18, 2014