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

Recruiting in Palo Alto (17 mi)

+23 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Actinium Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care in patients with Active, Relapsed or Refractory Acute Myeloid Leukemia (AML).

Eligibility Criteria

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.

Inclusion Criteria

My liver is working well.

Have a central venous catheter line in place

Have an expected survival of > 60 days

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Exclusion Criteria

Currently receiving any other active investigational agents

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

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

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Treatment Details

Interventions

Conventional Care (Other)
HCT (Stem Cell Transplant)
Iomab-B (Radioimmunotherapy)

Trial OverviewThe 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.

Participant Groups

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.