COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Relapse Prophylaxis With N-803 for AML and MDS Pts Following Allo HSCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02989844
Recruitment Status : Suspended (COVID-19)
First Posted : December 12, 2016
Last Update Posted : March 25, 2020
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief Summary:
This is a single-arm, multi-center Phase II trial using IL-15 super-agonist complex (N-803 formerly known as Alt-803) maintenance after allogeneic hematopoietic cell transplant (alloHCT) for acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia (AML) Myelodysplastic Syndrome (MDS) Drug: N-803 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relapse Prophylaxis With IL-15 Super Agonist N-803 in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome Following Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: N-803 Drug: N-803
N-803 at 6 mcg/kg SQ Day 1 of a 4 week (28 day) cycle with ± 1 week window Continue N-803 every 4 weeks for 10 doses or until relapse, unacceptable toxicity, or patient refusal, whichever comes earlier.
Other Name: Nant-803

Primary Outcome Measures :
  1. Incidence of Relapse [ Time Frame: 24 months ]
    Efficacy of N-803 as measured by the cumulative incidence of relapse between the 1st dose of N-803 and 2 years after a reduced intensity conditioning (RIC) allogeneic hematopoietic cell transplant (alloHCT)

Secondary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: 12 months ]
    Frequency of adverse and serious adverse events

  2. Incidence of acute graft-versus-host disease [ Time Frame: Day 100 ]
    Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)

  3. Incidence of acute graft-versus-host disease [ Time Frame: Day 180 ]
    Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)

  4. Chronic GVHD [ Time Frame: 1 year ]
    Incidence of acute graft-versus-host disease

  5. Minimal residual disease (MRD) [ Time Frame: Day 100, 1 year ]
    Incidence of minimal residual disease (MRD) post-transplant

  6. Overall Survival [ Time Frame: 1 year post transplant ]
    Incidence of overall survival at one year

  7. Non-Relapse mortality [ Time Frame: 1 year ]
    Incidence of non-relapse mortality

  8. Relapse [ Time Frame: 2 Years ]
    Incidence of relapse at 2 years after alloHCT stratified by number of doses of N-803 (1-3 or 4-10)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Diagnosis of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant using a reduced intensity conditioning is planned or has been performed and patient is prior to day 60 post-transplant.
  2. Able to begin study treatment between day +42 and day +60 after the transplant and meets the following transplant related requirements:

    • Sustained neutrophil (ANC > 1000/mcL) and platelet (> 30,000/mcL) engraftment
    • >50% donor myeloid and lymphoid chimerism blood or bone marrow on most recent bone marrow (BM) evaluation
    • No evidence of recurrent disease on most recent bone marrow evaluation (day 21 or 28 post-transplant is acceptable)
    • No morphologic evidence of relapse (< 5% bone marrow blasts) on most recent BM evaluation (Day 21 or 28 post-transplant is acceptable)
    • Being followed in the outpatient setting (not an inpatient)
    • No plan of giving other anti-cancer treatment directed at diseases under study (i.e. maintenance therapy [e.g. sorafenib for FLT3m+ AML or hypomethylating therapy], additional therapy for MRD)
  3. If acute GVHD is present it must be clinically improving on topical steroids and/or on low dose systemic steroids (≤ 0.3 mg/kg/day prednisone) and with clinical stability for at least 1 week prior to determination of eligibility. GVHD prophylaxis will be continued per individual institutional standard practice
  4. One of the following donor graft sources used for the transplant:

    • Group 1: sibling donor
    • Group 2: haploidentical donor [with post-transplant cyclophosphamide]
    • Group 3: unrelated donor
    • Group 4: unrelated umbilical cord blood
  5. Karnofsky performance status ≥ 70%
  6. Adequate organ function within 14 days of study enrollment defined as:

    • Renal: serum creatinine: ≤ 2.0 mg/dL
    • Hepatic: SGOT ≤ 3 x upper limit of institutional normal (ULN)
  7. Sexually active females of child-bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy.
  8. Voluntary written consent prior to the performance of any research related procedures

Exclusion Criteria:

  1. Prior N-803 (previously known as ALT-803)
  2. Pregnant or breastfeeding - N-803 is an investigational agent. Women of child bearing potential must have a negative pregnancy test at screening.
  3. Class II or greater New York Heart Association Functional Classification criteria or serious cardiac arrhythmias likely to increase the risk of cardiac complications of cytokine therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy)
  4. Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval > 500 milliseconds)
  5. Active uncontrolled bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and must be afebrile for at least 24 hours at time of enrollment.
  6. Active autoimmune disease requiring immunosuppressive therapy (GVHD prophylaxis is permitted per institutional practice)
  7. History of severe asthma and currently on chronic medications (mild asthma requiring inhaled steroids only is eligible)
  8. Received any investigational agent within the 14 days before the start of study treatment (1st dose of N-803)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02989844

Layout table for location information
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Layout table for investigator information
Principal Investigator: Claudio Brunstein, MD, PhD University of Minnesota
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota Identifier: NCT02989844    
Other Study ID Numbers: 2016LS058
MT2016-07 ( Other Identifier: University of Minnesota Masonic Cancer Center )
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions