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Protocol No. UW17102

Principal Investigator Hematti, Peiman

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia

Objective The purpose of this research study is to determine the effect of an investigational cell therapy, known as NLA101, on possibly reducing the rate of infections after chemotherapy. Investigational means that NLA101 is still being studied and can only be given as part of a research study. NLA101 is made in a laboratory from umbilical cord blood cells. These cells are like the blood cells in your bone marrow that make red blood cells, white blood cells and platelets. During your treatment for acute myeloid leukemia (AML), you will very likely develop a condition called “chemotherapy-induced neutropenia”, which means you have a lower than normal number of neutrophils (a type of white blood cell) in your blood stream after chemotherapy. Patients with neutropenia may be at higher risk of getting infections, which can be severe and may become life-threatening. NLA101 may provide a quick and temporary source of neutrophils, which may be helpful to prevent infections in patients that have chemotherapy-induced neutropenia after receiving chemotherapy

Treatment You will be randomized into one of four groups, if you are in one of the first three groups, you will receive either a low, medium, or a high dose of NLA101 after each cycle of standard of care chemotherapy, for a maximum of three cycles of chemotherapy. You will receive the same NLA101 dose every time it is infused. If you are in the fourth group, you will receive standard of care chemotherapy alone

Description Phase 2, dose-finding study of NLA101 in Adults receiving chemotherapy for Acute Myeloid Leukemia

Key Eligibility
  • Age ≥18
  • Untreated de novo or secondary AML (including AML that has progressed from myelodysplastic syndrome) and histologically documented diagnosis as defined by World Health Organization Classification
  • Eligible (according to institutional guidelines) for a planned AML treatment regimen to include at least 2 cycles of chemotherapy. The treatment regimen must be a standard AML regimen that will result in moderate to severe myelosuppression and have curative intent. This includes single agent therapies that are known to result in moderate to severe myelosuppression (with Medical Monitor approval)
  • Life expectancy of at least 12 weeks
  • Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2 or Karnofsky Status of 50 to 100
  • Adequate cardiac, renal, and hepatic functions
  • Females of reproductive potential (defined as all women physiologically capable of becoming pregnant) must agree to use highly effective methods of contraception during the study and for 90 days after the last dose of NLA101
  • Males who have partners of reproductive potential must agree to use an effective barrier contraceptive method during the study and for 90 days after the last dose of NLA101
    EXCLUSION:
  • Extramedullary disease in the absence of bone marrow or blood involvement
  • Acute promyelocytic leukemia (APL) with PML-RARA: Subjects with suspected APL at the time of diagnosis will be excluded unless the absence of the PML-RARA is documented
  • Prior AML therapy, with the exception of intrathecal chemotherapy or emergent radiation for myeloid sarcoma
  • Concurrent malignancy requiring active treatment with chemotherapy, immunotherapy, or radiation
  • Prior allotransplant, including allogeneic hematopoietic cell transplant or solid organ allogeneic transplant
  • Active/chronic human immunodeficiency virus, hepatitis C virus, or hepatitis B virus infection based on serologic testing within 3 months of randomization
  • An uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate treatment at the time of randomization
  • Pregnant or lactating or planning to become pregnant
  • Steroids (maximum allowable dose is ≤ 20 mg prednisone each day). Pretreatment containing steroids may be given for necessary medications (e.g., intravenous Ig). Physiologic replacement dosing of steroids (≤ 12 mg/m2/day hydrocortisone or equivalent [≤ 3 mg/m2/day prednisone or ≤ 0.45 mg/m2/day dexamethasone]) is allowed. Topical steroids, inhaled steroids, and intrathecal steroids (for central nervous system relapse prophylaxis) are permitted
    Presence or history of any of the following within 6 months prior to randomization:
  • New York Heart Association class III or IV congestive heart failure, Uncontrolled and sustained hypertension, Clinically significant cardiac dysrhythmia or clinically significant electrocardiogram (ECG) abnormality (e.g., QTcF > 470 msec), Myocardial infarction, Unstable angina pectoris,Coronary/peripheral artery bypass graft,Cerebrovascular accident ,Transient ischemic attack

  • Applicable Disease Sites Leukemia

    Status Open

    Participating Institutions UW Hospital and Clinics