Everolimus (RAD001) in Elderly Patients With Acute Myeloid Leukemia

• Status: Unknown status
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main goal of this study is to assess the safety and tolerability of RAD001 in combination with low-dose cytarabine in acute myeloid leukemia patients unfit for intensive chemotherapy. The secondary goals are to investigate the likely causes of drug response or failure.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayside Health
• Treatments: Azacitidine; Everolimus; Sirolimus

Criteria

Untreated AML patients (defined by WHO 2008 criteria) over the age of 60 or relapsed/refractory AML over the age of 18 who have received up to 2 previous lines of intensive chemotherapy

• No prior failure to achieve at least a PR with Azacitidine or Everolimus

• Provision of written informed consent

• Secondary AML (including therapy-related) are included

• Life expectancy of greater than 3 months in relation to diseases other then AML/MDS

• ECOG performance status 0 - 3

• Electrolyte levels (potassium, calcium (albumin-adjusted), magnesium, phosphorous) within normal limits (WNL) or easily correctable with supplements

• Adequate hepatic function as defined by bilirubin ≤ 1.5 x the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN

• Adequate renal function, with serum creatinine ≤ 1.5 x ULN or GFR > 30 ml/minute

• Patients with no uncontrolled active infection

• Hydroxyurea ceased 48 hours prior to study therapy

Exclusion Criteria

• Any serious medical or psychiatric conditions which the investigator feels may interfere with the patient's ability to give informed consent or participate in the procedures or evaluations of the study

• History of major non-compliance to medication

• Evidence of CNS leukemia

• Uncontrolled viral infection with known HIV or Hepatitis type B or C

• Currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication

• Any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardize compliance with the protocol

• Males with a female partner of childbearing potential do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following the date of last dose