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

AML Clinical Trial

Official title:

Rapid Profiling of Bone Marrow, at Presentation and After 5 Days of Induction Therapy, a Sensitive Method for Identifying Resistant AML Clones

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01268800
• Other study ID #: 0588-10-rmb-CTIL
• Status: Recruiting
• Phase: N/A
• First received: December 30, 2010
• Last updated: May 5, 2014
• Start date: February 2011

Study information

• Verified date: May 2014
• Source: Rambam Health Care Campus
• Contact: Yishai ofran, MD
• Phone: 972-4-5842541
• Email: y_ofran[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• AML

Locations

Country	Name	City	State
Israel	Rambam medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission	Bone marrow blasts <5% upon recovery from induction therapy	30-54 days	No
Secondary	Overall survival		two years	No
Secondary	relapse rate		two years	No