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

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ClinicalTrials.gov Identifier: NCT02989844
Recruitment Status : Suspended (Pending Amendment)
First Posted : December 12, 2016
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE November 2, 2016
First Posted Date  ICMJE December 12, 2016
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE April 12, 2017
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
Incidence of Relapse [ Time Frame: 12 months ]
Efficacy of ALT-803 as measured by the cumulative incidence of relapse between the 1st dose of ALT-803 (approximately day 70) and 12 months after a reduced intensity conditioning (RIC) allogeneic hematopoietic cell transplant (alloHCT)
Change History Complete list of historical versions of study NCT02989844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Incidence of Adverse Events [ Time Frame: 12 months ]
    Frequency of adverse and serious adverse events
  • 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)
  • 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)
  • Chronic GVHD [ Time Frame: 1 year ]
    Incidence of acute graft-versus-host disease
  • Minimal residual disease (MRD) [ Time Frame: Day 100, 1 year ]
    Incidence of minimal residual disease (MRD) post-transplant
  • Overall Survival [ Time Frame: 1 year post transplant ]
    Incidence of overall survival at one year
  • Non-Relapse mortality [ Time Frame: 1 year ]
    Incidence of non-relapse mortality
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • Incidence of Adverse Events [ Time Frame: 12 months ]
    Frequency of adverse and serious adverse events
  • 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)
  • 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)
  • Chronic GVHD [ Time Frame: 1 year ]
    Incidence of acute graft-versus-host disease
  • Minimal residual disease (MRD) [ Time Frame: Day 100, 1 year ]
    Incidence of minimal residual disease (MRD) post-transplant.
  • Overall Survival [ Time Frame: 1 year ]
  • Non-Relapse mortality [ Time Frame: 1 year ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Relapse Prophylaxis With N-803 for AML and MDS Pts Following Allo HSCT
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myelogenous Leukemia (AML)
  • Myelodysplastic Syndrome (MDS)
Intervention  ICMJE 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
Study Arms Experimental: N-803
Intervention: Drug: N-803
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: December 7, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02989844
Other Study ID Numbers  ICMJE 2016LS058
MT2016-07 ( Other Identifier: University of Minnesota Masonic Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claudio Brunstein, MD, PhD University of Minnesota - Clinical and Translational Science Institute
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP