Study of Iomab-B Prior to HCT vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory AML



Status:Recruiting
Conditions:Other Indications, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology, Other
Healthy:No
Age Range:55 - Any
Updated:4/3/2019
Start Date:June 2016
End Date:June 2020
Contact:Vijay Reddy, MD
Email:vreddy@actiniumpharma.com

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A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia

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.


Inclusion Criteria:

- Have active, relapsed or refractory Acute Myeloid Leukemia (AML). Active, relapsed or
refractory AML is defined as either (1) primary induction failure (PIF) after 2 or
more cycles of chemotherapy, (2 first early relapse after a remission duration of
fewer than 6 months, (3) relapse refractory to salvage combination chemotherapy
containing high-dose AraC, and (4) second or subsequent relapse

- Have documented CD45 expression by leukemic cells via flow cytometry (a "blast gate"
on CD45 vs. side scatter analysis consistent with AML)

- Be at least 55 years of age

- Have a circulating blast count of less than 10,000/mm3 (control with hydroxyurea is
allowed)

- Have a calculated creatinine clearance (Cockroft-Gault equation) > 50 mL/min

- Have adequate hepatic function (bilirubin, aspartate aminotransferase (AST), and
alanine aminotransferase (ALT), defined as ≤ 2 times the upper limit of normal [ULN])

- Have a Karnofsky score ≥ 70

- Have an expected survival of > 60 days

- Have a central venous catheter line in place prior to study treatment administration

- Have 8/8 allele-level, related or unrelated, medically cleared HSC donor matching at
human leukocyte antigen (HLA)-A, HLA-B, HLA-C, and DRB-1

- Women of childbearing potential, be surgically sterile or agree to practice abstinence
or utilize acceptable contraception (intrauterine, injectable, transdermal, or
combination oral contraceptive) through 1-year post transplant; Males who are sexually
active with women of childbearing potential must be surgically sterile or using an
acceptable method of contraception (defined as barrier methods in conjunction with
spermicides) from time of screening through 12 weeks after last dose of study drug

- Be able to understand the study procedures, agree to participate in the study program,
and voluntarily provide written Informed Consent

Exclusion Criteria:

- Have circulating HAMA noted on initial screening

- Have received prior radiation to maximally tolerated levels to any critical normal
organ

- Have active leukemic central nervous system (CNS) involvement, as defined by any
leukemic blasts detected in the cerebrospinal fluid (CSF) by morphology or flow
cytometry and/or any chloromas detected by CNS imaging

- Have previously received HCT

- Have clinically significant cardiac disease (NYHA Class III or IV); clinically
significant arrhythmia i.e. ventricular tachycardia, ventricular fibrillation, or
"Torsade de Pointes". Myocardial infarction with uncontrolled angina within 6 months,
congestive heart failure, or clinical significant cardiomyopathy

- Have abnormal QTcF (>450milliseconds) after electrolytes have been corrected (at least
two different ECG readings and at least 15 minutes between readings)

- Have current or prior positive test results for human immunodeficiency virus (HIV) or
hepatitis B (HBV) or C. Subjects who have positive HBV test results due to having been
previously vaccinated against hepatitis B, as evidenced by negative hepatitis B
surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive
antibody to the HBsAg (anti-HBs) are not excluded

- Have active serious infection uncontrolled by antibiotics or antifungals

- Have acute promyelocytic leukemia and the associated cytogenic translocation t:(15/17)

- Have active malignancy within 2 years of entry. Active malignancy is defined as those
malignancies requiring treatment with anti-cancer therapy or in the event of indolent
malignancies, having measurable disease. Exceptions to this exclusion include:
myelodysplastic syndrome, treated non-melanoma skin cancer, completely resected Stage
0 or 1 melanoma no less than 1 year from resection, carcinoma in situ or cervical
intraepithelial neoplasia, and successfully treated organ-confined prostate cancer
with no evidence of progressive disease based on prostate specific antigen (PSA)
levels and are not on active therapy

- Have received an antibody therapy within 3 weeks

- Have a perceived inability to tolerate diagnostic or therapeutic procedures,
particularly treatment in radiation isolation

- Currently receiving any other active investigational agents
We found this trial at
19
sites
Houston, Texas 77030
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Cleveland, OH
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Columbus, OH
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Dallas, TX
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Gilbert, Arizona 85234
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10065
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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542 King Edward Avenue
Ottawa, Ontario K1N 6N5
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Ottawa,
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Rochester, Minnesota 55905
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Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Stony Brook, New York 11794
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Westwood, Kansas 66205
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