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Cancer Vaccine

DR-18 for Leukemia

Phase 1

Recruiting

Led By Elizabeth Krakow

Research Sponsored by Fred Hutchinson Cancer Center

Eligibility Criteria Checklist

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

Must have

No history of grade 3 or 4 acute GvHD after the most recent HCT

Stable or reducing immune suppression in the preceding 4 weeks without GVHD flares

Must not have

Uncontrolled cardiac arrhythmias

Active moderate-severe thrombotic microangiopathy (TMA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months and at 12 months after first dose of dr-18

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new treatment called decoy-resistant interleukin-18 (DR-18) for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome

Who is the study for?

This trial is for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has returned or persisted after a stem cell transplant. Participants must have had the transplant as their prior treatment.

What is being tested?

The trial is testing DR-18, a new form of interleukin-18, to see if it's safe and effective in treating AML/MDS after relapse or persistence post-transplant. It also involves bone marrow aspiration and biospecimen collection for study purposes.

What are the potential side effects?

Potential side effects include immune system reactions, possible inflammation due to cytokine activity, and general discomfort from bone marrow aspiration procedures.

Eligibility Criteria

Inclusion Criteria

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

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I have not had severe GvHD after my last stem cell transplant.

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My immune suppression has been stable or decreasing without any flare-ups in the last month.

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My last stem cell transplant was from a fully matched donor.

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No suitable FDA-approved targeted therapy for my AML or MDS, or I couldn't tolerate it.

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I can carry out normal activities with minimal symptoms.

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I have not had severe chronic graft-versus-host disease after my last stem cell transplant.

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My AML or MDS has come back or didn't go away after a stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled heart rhythm problems.

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I have a severe blood clotting disorder affecting my small blood vessels.

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I have needed extra oxygen in the last 2 weeks.

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My heart's pumping ability is significantly reduced.

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My kidney function is low, with a filtration rate under 30 mL/min.

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I have not had a major heart problem that needed ER or hospital care in the last 4 weeks.

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I currently have an infection that is not under control.

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I have had a seizure or significant neurological disease recently.

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My liver tests are not more than 5 times the normal limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months and at 12 months after first dose of dr-18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months and at 12 months after first dose of dr-18

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months and at 12 months after first dose of dr-18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of dose-limiting toxicities (DLTs)

Secondary study objectives

Composite complete response (CR)

Incidence of grade 1-4 cytokine release syndrome (CRS)

Incidence of grade 2 and grade 3-4 acute graft versus host disease (GVHD)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (DR-18)Experimental Treatment3 Interventions

INDUCTION: Patients receive DR-18 SC once weekly on approximately days 0, 7, 14, and 21. MAINTENANCE: Two weeks after induction treatment, patients without grade 3-4 acute GVHD, grade 2 acute GVHD requiring ongoing systemic immunosuppression, or moderate/severe chronic GVHD may receive DR-18 SC once weekly on approximately days 35, 42, 49 and 56. Additionally, patients undergo blood and bone marrow sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Bone Marrow Aspiration

2011

Completed Phase 2

~1740