Status:
TERMINATED
Physical Conditioning and Decitabine for Newly Diagnosed AML Patients Age ≥ 60
Lead Sponsor:
Emory University
Conditions:
Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
STUDY BACKGROUND AND PURPOSE: Acute myelogenous leukemia (AML) is a common type of blood cancer in adults, and is more common with increasing age. AML is harder to treat in older patients, with typic...
Detailed Description
Primary Objectives: • Number of patients age 60 and older with newly diagnosed AML and who are not candidates for standard induction chemotherapy who complete an 8-week program of physical conditioni...
Eligibility Criteria
Inclusion
- Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria
- Age ≥ 60 years
- Patient not eligible for (immediate) standard induction chemotherapy based on the opinion of the treating physician and the frailty score
- Provide signed written informed consent
- Be able to comply with study procedures and follow-up examinations
- Adequate heart function with echocardiogram demonstrating ejection fraction ≥ 45% with no evidence of systolic dysfunction
- Adequate renal and hepatic function:
- Total bilirubin ≤ 2x institutional Upper Limit of Normal (ULN); and
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN; and
- Serum creatinine ≤ 2 times the upper limit of normal
- ECOG performance \< 4
- Patients with a history of carcinoma in remission (on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma) are included in the study.
Exclusion
- Diagnosis of acute promyelocytic leukemia (APL, French-American-British \[FAB\] classification M3 or WHO classification of APL with t(15;17)(q22;q12)), (PML/retinoic acid receptor alpha \[RARa\] and variants)
- Prior treatment with decitabine for myelodysplastic syndrome (MDS) or AML
- Relapsed or refractory AML
- Rapidly doubling white cell count uncontrolled with hydroxyurea
- Coronary artery disease with angina limiting exercise capability
- Joint disease limiting exercise capability
- Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 2 or less prior to first dose of study drug
- Psychiatric disorders that would interfere with consent, study participation, or follow-up
- Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- Any other severe concurrent disease, or serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy
- No social support or inability to attend study-related visits
- Carcinoma requiring systemic chemotherapy or radiation therapy
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02234037
Start Date
November 1 2013
End Date
May 1 2016
Last Update
January 30 2017
Active Locations (1)
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1
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322