Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Myelogenous Leukemia Acute Myeloid Leukemia AML Bone Marrow Transplant Leukemia, Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Myeloid, Acute Myelogenous Leukemia, Acute Myeloid Leukemia, Acute

Keywords

Acute Myeloid LeukemiaLeukemia, Acute MyeloidMyeloid Leukemia, AcuteBone Marrow Cell TransplantTransplant, Bone MarrowHCTHSCTRefractory AMLRelapsed AMLBC8I-131IomabIomab-BCD45IodineIodine-131131-IAMLBMTRadioimmunotherapy

Outcome Measures

Primary Outcomes (1)

Durable Complete Remission (dCR)
Defined as CR or CRp lasting 180 days or more from time of initial CR or CRp is documented with evidence of subsequent relapse
6 months from time of initial CR or CRp

Secondary Outcomes (2)

Overall Survival (OS) following randomization to Iomab-B versus Convetional Care
Over a 5 year period
Event-Free Survival
Over a 5 year period

Study Arms (2)

Iomab-B

EXPERIMENTAL

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

Drug: Iomab-BProcedure: HCT

Conventional Care

ACTIVE COMPARATOR

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.

Interventions

Iomab-BDrug

Iomab-B

Conventional CareDrug

Conventional Care

HCT

Eligibility Criteria

Age55 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have active, relapsed or refractory Acute Myeloid Leukemia (AML). Active, relapsed or refractory AML is defined as any one of the following (1) primary induction failure, or (PIF) after 2 or more cycles of therapy, or (2) first early relapse after a remission duration of fewer than 6 months, or (3) relapse refractory to salvage combination chemotherapy, or (4) second or subsequent relapse

Sponsors & Collaborators

Actinium Pharmaceuticals
Industrylead

Study Sites (24)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Mayo Clinic

Jacksonville, Florida, 32224, United States

Loyola University Medical Center

Maywood, Illinois, 60153, United States

University of Iowa

Iowa City, Iowa, 52242, United States

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Related Publications (2)

Gyurkocza B, Nath R, Seropian S, Choe H, Litzow MR, Abboud C, Koshy N, Stiff P, Tomlinson B, Abhyankar S, Foran J, Hari P, Chen G, Al-Kadhimi Z, Kebriaei P, Sabloff M, Orozco JJ, Jamieson K, Silverman M, Van Besien K, Schuster M, Law AD, Larkin K, Pandit-Taskar N, Rowley SD, Munshi P, Cook R, Levy MY, Lazarus HM, Sandmaier BM, Pagel JM, Reddy V, MacDougall J, McNamara K, Spross J, Haeuber E, Vusirikala M, Nahar A, Desai A, Giralt S. Randomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML. J Clin Oncol. 2025 Jan 10;43(2):201-213. doi: 10.1200/JCO.23.02018. Epub 2024 Sep 19.
PMID: 39298738DERIVED
Walter RB. Where do we stand with radioimmunotherapy for acute myeloid leukemia? Expert Opin Biol Ther. 2022 May;22(5):555-561. doi: 10.1080/14712598.2022.2060735. Epub 2022 Mar 31.
PMID: 35350938

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

Avinash Desai, MD
Actinium Pharmaceuticals
STUDY CHAIR

Enrollment

153 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 27, 2016

Study Start

June 2016

Date type not reported

This date has not been verified as actual or estimated.

Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Iomab-B

Conventional Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Iomab-B

Conventional Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (24)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations