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

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Unknown status

CT.gov ID

NCT01268800

Collaborator

(none)

Enrollment

Location

Study Details

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	Intervention/Treatment	Phase
AML

Study Design

Study Type:

Observational

Anticipated 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 :

Feb 1, 2011

Anticipated Primary Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
AML induction Adults AML patients who were referred for intensive induction therapy

Outcome Measures

Primary Outcome Measures

complete remission [30-54 days]
Bone marrow blasts <5% upon recovery from induction therapy

Secondary Outcome Measures

Overall survival [two years]
relapse rate [two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Rambam medical center	Haifa		Israel	31096

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Yishai Ofran, MD, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT01268800

Other Study ID Numbers:

0588-10-rmb-CTIL

First Posted:

Dec 31, 2010

Last Update Posted:

May 6, 2014

Last Verified:

May 1, 2014

Keywords provided by Rambam Health Care Campus

AML

Induction

Study Results

No Results Posted as of May 6, 2014