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Phase III

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

  • Study HIC#:1607018056
  • Last Updated:07/15/2021

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.

  • Start Date01/25/2021
  • End Date12/31/2021

Trial Purpose and Description

Primary Outcome Measures:

  • 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 [ Time Frame: 6 months from time of initial CR or CRp ]

Secondary Outcome Measures:

  • Overall Survival (OS) at 1 year from randomization [ Time Frame: 1-year following randomization ]

Eligibility Criteria

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, HSC donor matching at human leukocyte antigen (HLA)-A, HLA-B, HLA-C, and DRB-1
  • For 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; For 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 known 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. Exceptions to this exclusion include: treated non-melanoma skin cancer, 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, with the exception of FLT3 inhibitors, such as sorafenib. FLT3 inhibitors can be administered until 3 days prior to the Therapeutic Infusion in the Iomab-B Treatment group and 3 days prior to the start of the salvage chemotherapy regimen in the Conventional Care Treatment group.

Sub-Investigators

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