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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.
Select...
My leukemia has spread to my brain or spinal cord.

Timeline

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

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
~16 spots leftby Oct 2025
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