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Iomab-B + HCT for Acute Myeloid Leukemia (SIERRA Trial)

Phase 3

Waitlist Available

Research Sponsored by Actinium Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Have 8/8 allele-level, medically cleared HSC donor matching at HLA-A, HLA-B, HLA-C, and DRB-1

Be at least 55 years of age

Must not have

Clinically significant cardiac disease or arrhythmia

Active serious infection uncontrolled by antibiotics or antifungals

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over a 5 year period

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new treatment for AML patients who have relapsed or are unresponsive to other treatments. The new treatment consists of a reduced intensity conditioning regimen in conjunction with Iomab-B and allogeneic hematopoietic stem cell transplant.

Who is the study for?

This trial is for people aged 55 or older with active, relapsed, or refractory Acute Myeloid Leukemia (AML) who haven't had a bone marrow transplant before and don't have HIV/HBV/HCV. They need to be in good enough health to participate, have a compatible stem cell donor, and agree to use contraception if of childbearing potential.

What is being tested?

The study tests Iomab-B followed by a Reduced Intensity Conditioning regimen and hematopoietic stem cell transplant (HCT), compared with conventional care treatments for AML. The goal is to see if Iomab-B can improve outcomes for these patients.

What are the potential side effects?

Potential side effects of Iomab-B may include reactions related to radiation exposure since it's a radiotherapy drug. These could range from mild skin irritation at the injection site to more serious effects on blood cells and organs like the liver.

Eligibility Criteria

Inclusion Criteria

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

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I have a perfect match for a stem cell transplant donor.

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I am 55 years old or older.

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I am able to care for myself but may not be able to do active work.

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My AML is active, has returned, or is not responding to treatment.

Exclusion Criteria

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

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I do not have any serious heart conditions or irregular heartbeats.

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I have a serious infection that isn't getting better with antibiotics or antifungals.

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My leukemia is a specific type with a unique genetic marker.

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I have had radiation therapy targeting vital organs.

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I have had a bone marrow or stem cell transplant.

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My leukemia has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over a 5 year period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over a 5 year period

This trial's timeline: 3 weeks for screening, Varies for treatment, and over a 5 year period for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Durable Complete Remission (dCR)

Secondary study objectives

Event-Free Survival

Overall Survival (OS) following randomization to Iomab-B versus Convetional Care

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Iomab-BExperimental Treatment2 Interventions

Iomab-B in conjunction with a Reduced Intensity Conditioning (RIC) regimen containing Fludarabine and low-dose Total Body Irradiation (TBI) prior to allogeneic HCT

Group II: Conventional CareActive Control2 Interventions

Defined as Investigator's choice of salvage chemotherapy with any combination of the following agents: Azacitidine (not allowed as a single agent), Carboplatin, Cladribine, Clofarabine, Cyclophosphamide, Cytarabine, Daunorubicin, Decitabine (not allowed as a single agent with the exception of patients with documented TP53 mutations who have not previously received 10-day regimens of single agent decitabine), Doxorubicin, Enasidenib, Etoposide, Fludarabine, Gemtuzumab ozogamicin, Idarubicin, Ivosidenib (for subjects with IDH1 mutation), L-Asparaginase, Midostaurin (for FLT3 mutant or FLT3-ITD subjects only, not allowed as single agent), Mitoxantrone, Sorafenib (for FLT3 mutant or FLT3-ITD subjects only, not allowed as single agent), Thioguanine, Topotecan, Venetoclax (in combination with a hypomethylating agent). Chemotherapy agents not listed above may be administered after providing clinical justification and receiving medical monitor approval prior to initiation of treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HCT

2008

Completed Phase 3

~870

0 / 10Eligibility criteria met