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Cytokine

IL-12 for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Mark Minden, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new treatment for AML that has returned or is likely to return. The treatment involves modifying the patient's AML cells to produce IL-12, and then giving the cells back to the patient. The trial will assess the safety and effectiveness of this approach.

Who is the study for?

This trial is for adults with Acute Myeloid Leukemia (AML) whose disease has returned or is likely to, and who can't have a bone marrow transplant. They must have had prior treatment but not be in remission, with stable white blood cell counts and less than 10% blast cells post-therapy. Participants need functioning kidneys and liver, agree to contraception use, are not pregnant, and can follow study procedures.Check my eligibility

What is being tested?

The trial tests the safety of using modified AML cells that produce IL-12 in patients. It's a phase 1 study focusing on those who cannot undergo bone marrow transplants to see if this approach helps manage their leukemia by enhancing their immune response against cancer cells.See study design

What are the potential side effects?

While specific side effects for IL-12 modified AML cells aren't detailed here, common ones may include flu-like symptoms such as fever and chills, fatigue, nausea or vomiting due to immune system activation; organ inflammation might also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bone marrow has less than 10% blast cells after initial treatment and I don't want more intense therapy.

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My cancer is in remission, but there's a high risk it could come back.

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I am 18 or older with acute myeloid leukemia (AML).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of side effects by type and severity

Secondary outcome measures

Length of time patient is alive

Levels of IL-12

Levels of acute myeloid leukemia (AML)

Trial Design

1Treatment groups

Experimental Treatment

Group I: IL-12Experimental Treatment1 Intervention

A single dose of IL-12, given intravenously.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IL-12

2007

Completed Phase 2

~190

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,171 Total Patients Enrolled

Ozmosis Research Inc.Industry Sponsor

20 Previous Clinical Trials

5,006 Total Patients Enrolled

Mark Minden, M.D.Principal InvestigatorPrincess Margaret Cancer Centre

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment period still open for this experiment?

"The information hosted on clinicaltrials.gov indicates that this trial has ceased accepting new patients; the original posting was September 1, 2015 and it was last updated April 16, 2021. Nonetheless, 1539 other medical studies are available at present for potential enrollees."

Answered by AI