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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over a 5 year period

Awards & highlights

SIERRA 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.Check my eligibility

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.See study design

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.

SIERRA Trial 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.

SIERRA Trial 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

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

Primary outcome measures

Durable Complete Remission (dCR)

Secondary outcome measures

Event-Free Survival

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

SIERRA 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Actinium PharmaceuticalsLead Sponsor

6 Previous Clinical Trials

109 Total Patients Enrolled

Mark Berger, MDStudy DirectorActinium Pharmaceuticals

5 Previous Clinical Trials

67 Total Patients Enrolled

Avinash Desai, MDStudy ChairActinium Pharmaceuticals

4 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

Conventional Care (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02665065 — Phase 3

Acute Myeloid Leukemia Research Study Groups: Conventional Care, Iomab-B

Acute Myeloid Leukemia Clinical Trial 2023: Conventional Care Highlights & Side Effects. Trial Name: NCT02665065 — Phase 3

Conventional Care (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02665065 — Phase 3

Frequently Asked Questions

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

Are there any unfilled vacancies in this clinical trial for new test subjects?

"According to the latest information available on clinicaltrials.gov, this particular trial is not currently looking for patients as all slots have been filled. This study was first posted on June 1st, 2016 but was updated as recently as February 22nd, 2022. There are 1610 other trials that are presently recruiting patients."

Answered by AI

Could you please tell me how many active test locations there are for this experiment?

"There are 24 different sites where this trial is being conducted, which are located in Washington, Gilbert, Westwood and other locations. If you enroll in the study, it would be beneficial to select a site that is closest to your location to minimize travel requirements."

Answered by AI

Do we have the go-ahead from the FDA to use Iomab-B?

"Iomab-B safety was given a 3 because this is a Phase 3 trial. This means that not only is there some data supporting efficacy, but multiple rounds of data exist which support safety."

Answered by AI