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

  • STATUS
    Recruiting
  • End date
    Dec 11, 2026
  • participants needed
    150
  • sponsor
    Actinium Pharmaceuticals
Updated on 11 April 2021
remission
stem cell transplantation
myeloid leukemia
hydroxyurea
flow cytometry
direct bilirubin
myeloablative conditioning
leukemia
refractory acute myeloid leukemia (aml)
blast cells

Summary

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).

Description

SIERRA is a pivotal Phase 3 randomized controlled study of Iomab-B in Relapsed or Refractory AML patients. The SIERRA trial has a primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival following randomization to Iomab-B, as well as Event-Free Survival. Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning.

Details
Condition Bone marrow transplant, Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), acute myelogenous leukemia, anll, acute myeloblastic leukemia, bone marrow transplantation, bone marrow graft
Treatment Fludarabine, Total body irradiation, Iomab-B, Conventional Care, HCT, HCT, Mycofenolate mofetil (MMF), Cyclosporine or Tacrolimus
Clinical Study IdentifierNCT02665065
SponsorActinium Pharmaceuticals
Last Modified on11 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 (Cockcroft-Gault equation) > 50 mL/min
Have adequate hepatic function (direct 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 with a donor who is medically cleared. Syngeneic donors that meet these criteria are allowed
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 (including both allogeneic and autologous 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 clinically significant cardiomyopathy
Have abnormal QTcF (>450milliseconds) after electrolytes have been corrected (at least two different ECG readings and at least 15 minutes between readings). Subjects with paced rhythm or prolonged QTcF may be exempt from this exclusion if considered eligible for transplant per treating physician clinical judgement with optional cardiology consultation
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. Subjects who have positive hepatitis test results with adequate organ function as defined in the protocol 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 a perceived inability to tolerate diagnostic or therapeutic procedures, particularly treatment in radiation isolation
Currently receiving any other active investigational agents
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