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

NCT01268800 | Unknown

• 1 other identifier: 0588-10-rmb-CTIL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

AML

Keywords

AML; Induction

Outcome Measures

Primary Outcomes (1)

• complete remission

  Bone marrow blasts \<5% upon recovery from induction therapy

  30-54 days

Secondary Outcomes (2)

• Overall survival

  two years

• relapse rate

  two years

Study Arms (1)

AML induction

Adults AML patients who were referred for intensive induction therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (\>18) AML patients

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam medical center

Haifa, 31096, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood bone marrow and buccal smear

Study Officials

• Yishai Ofran, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yishai ofran, MD

CONTACT

972-4-5842541; y_ofran@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: December 31, 2010
• Study Start: February 1, 2011
• Primary Completion: August 1, 2014
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

IL (1)