Safety Study of Thioridazine in Combination With Cytarabine to Treat Relapsed or Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Thioridazine, Phase I, Clinical Trial
Study Type
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Thioridazine
Type: Drug
Overall Status
This is a Phase I trial investigating the safety of using thioridazine in addition to cytarabine in elderly patients with relapsed or refractory Acute Myeloid Leukemia.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 55 Years
Gender: Both
Criteria: Inclusion Criteria:

- Have a diagnosis of AML according to the WHO Classification1

- AML is refractory or relapsed (requiring at least 5% leukemic blasts in the bone marrow, regardless of the presence of other features such as new or recurrent dysplastic changes or extra medullary disease) according to the following definitions:

- Relapsed (defined as ≥ 5% leukemic blasts in the bone marrow) after three months from receiving up to three prior induction regimens.

- Refractory (defined as ≥ 5% leukemic blasts in the bone marrow) to not more than one prior induction regimen (defined as failure to achieve a CR or CRi following induction therapy).

- 55 years of age or older.

Exclusion Criteria:

- Receiving any other systemic anti-leukemic therapy (standard or investigational).

- Having received more than two prior chemotherapy lines for AML. Induction/consolidation therapy and bone marrow transplant are each considered a line of therapy.

- Having received previous AML therapy within four weeks of the first dose of study drug, with the exception of hydroxyurea.

- Clinical evidence suggestive of CNS involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the CSF.

- Acute promyelocytic leukemia.

- An ECOG performance status of 3 or more.

- Inadequate renal function (i.e., estimated GFR < 60 mL/min/1.73m2).

- Inadequate hepatic function (i.e., serum bilirubin > 1.5×ULN; AST, ALT and alkaline phosphatase > 2.5×ULN).

- Presence of acute or chronic GVHD.

- Presence of a 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).

- Having any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo induction therapy.

- Diagnosed with a condition that can prolong the QT interval (e.g., long QT syndrome) or have a QTc interval ≥ 470ms if male, or ≥ 480ms if female.

- Left ventricular ejection fraction less than 45%.

- History of uncontrolled cardiac arrhythmia.

- Known severe hypotensive or hypertensive heart disease.

- Prior malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values if hormonal therapy has been initiated or a radical prostatectomy has been performed.

- Known HIV positivity.

- Known pregnancy or lactating female.

- Presence of a psychiatric disorder that would interfere with consent, study participation, or follow-up.

- Unable to provide informed consent.
Juravinski Hospital & Cancer Centre
Hamilton, Ontario, Canada
Status: Recruiting
Contact: Ronan Foley, MD - 905-527-4322 -
Start Date
July 2014
Completion Date
January 2016
Ontario Clinical Oncology Group (OCOG)
Ontario Clinical Oncology Group (OCOG)
Record processing date processed this data on July 28, 2015 page