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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 25 March 2024
Main ID:  NCT02483312
Date of registration: 24/06/2015
Prospective Registration: Yes
Primary sponsor: University Health Network, Toronto
Public title: A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML)
Scientific title: Phase I Study of Autologous Acute Myelogenous Leukemia (AML) Cells Containing Lentivirus Engineering Expression of IL-12
Date of first enrolment: September 2015
Target sample size: 9
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/ct2/show/NCT02483312
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Canada
Contacts
Name:     Hassan Sibai, M.D.
Address: 
Telephone:
Email:
Affiliation:  Princess Margaret Cancer Centre
Name:     Hassan Sibai, M.D.
Address: 
Telephone: 416-946-4407
Email:
Affiliation: 
Name:     Hassan Sibai, M.D.
Address: 
Telephone: 416-946-4407
Email: Hassan.Sibai@uhn.ca
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient with AML and >=18 years of age.

- Agrees to participate in the study and signs the informed consent

- Viable cells are available for successful modification

- First or higher complete remission and have high risk features of relapse.

- Patients who have received prior treatment and are not in remission must have stable
white blood cell count and are not receiving any chemotherapy or desiring further
intensive treatment.

- Less than 10% blast cells in the bone marrow following induction or re-induction
therapy and not desiring further intensive treatment.

- Acceptable creatinine, Aspartate transaminase (AST), Alkaline phosphatase (ALP),
bilirubin lab results.

- Agree to use contraception

- Not pregnant

- Able to comply with study procedures

Exclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status >2

- Known persistent infection

- Known central nervous system (CNS) disease

- Greater than 10% blasts in the bone marrow or circulating blast cells

- Life expectancy < 2 months

- Receiving any chemotherapy, corticosteroids, Cox2 inhibitors or any non-drug therapies
with the intent of altering the immune response or kill leukemic cells within one week
prior to infusion of IL-12, except azacytidine.

- Patients who are HIV positive.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Acute Myeloid Leukemia
Intervention(s)
Biological: IL-12
Primary Outcome(s)
Number of side effects by type and severity [Time Frame: 2 years]
Secondary Outcome(s)
Length of time patient is alive [Time Frame: 2 years]
Levels of IL-12 [Time Frame: Day 28 to 2 years]
Levels of acute myeloid leukemia (AML) [Time Frame: Day 28 to 2 years]
Secondary ID(s)
OZM-068
DDP-IL-12
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ozmosis Research Inc.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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