NLA101 in Adults Receiving High Dose Chemotherapy for AML

Overview

About this study

Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects with AML.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Signed written informed consent obtained prior to any study procedures.
  • Age ≥ 18 (or legal age of majority for sites outside US).
  • Untreated de novo or secondary AML (including AML that has progressed from myelodysplastic syndrome) and histologically-documented diagnosis as defined by the 2016 World Health Organization (WHO) 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 based on an anthracycline and cytarabine backbone that will result in moderate to severe myelosuppression and have curative intent. Standard AML regimens that include an anthracycline and cytarabine component, and that are being investigated under a study protocol may be allowed upon consultation with Medical Monitor.
  • Life expectancy of at least 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 or Karnofsky Status of 50 to 100.
  • Adequate cardiac, renal, and hepatic functions as indicated by the following assessments: 
    • Cardiac: Left ventricular ejection fraction (LVEF) ≥ 45% by multigated acquisition;
    • (MUGA) scan or echocardiography within 8 weeks prior to randomization;
    • Renal: Calculated creatine clearance > 60 mL/min/1.73 m2 and serum (or plasma) creatinine ≤ 2.0 mg/dL (176.8 μmol/L) within 7 days prior to randomization;
    • Hepatic: Total bilirubin ≤ 2.5 x Institutional Upper Limit of Normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert’s syndrome (by history), or hemolysis, within 7 days prior to randomization.
  • 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.
  • A negative serum pregnancy test for female subjects of reproductive potential, within 14 days prior to randomization.

Exclusion Criteria:

  • Extramedullary disease in the absence of bone marrow or blood involvement.
  • Acute promyelocytic leukemia (APL) with PML-RARA.
  • 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.
  • Known hypersensitivity or history of hypersensitivity to dimethylsulfoxide (DMSO).
  • Active/chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kebede Begna, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

James Foran, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20411781

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