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

NCT02989844 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2016LS058MT2016-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myelogenous Leukemia (AML); Myelodysplastic Syndrome (MDS)

Outcome Measures

Primary Outcomes (1)

• Incidence of Relapse

  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)

  24 months

Secondary Outcomes (8)

• Incidence of Adverse Events

  12 months

• Incidence of Acute Graft-versus-host Disease

  Day 100

• Incidence of Acute Graft-versus-host Disease

  Day 180

• Chronic GVHD

  1 year

• Minimal Residual Disease (MRD)

  1 year

Study Arms (1)

N-803

EXPERIMENTAL

Drug: N-803

Interventions

N-803 DRUG

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.

Also known as: Nant-803

N-803

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• 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
• 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
• Karnofsky performance status ≥ 70%

You may not qualify if:

• Prior N-803 (previously known as ALT-803)
• Pregnant or breastfeeding - N-803 is an investigational agent. Women of child bearing potential must have a negative pregnancy test at screening.
• 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)
• Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval \> 500 milliseconds)
• 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.
• Active autoimmune disease requiring immunosuppressive therapy (GVHD prophylaxis is permitted per institutional practice)
• History of severe asthma and currently on chronic medications (mild asthma requiring inhaled steroids only is eligible)
• Received any investigational agent within the 14 days before the start of study treatment (1st dose of N-803)

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

ALT-803

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Results Point of Contact

• Title: Jeffrey Miller
• Organization: University of Minnesota, Masonic Cancer Center

mille011@umn.edu

612-625-7409

Study Officials

• Claudio Brunstein, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: December 12, 2016
• Study Start: April 12, 2017
• Primary Completion: March 19, 2022
• Study Completion: August 31, 2022
• Last Updated: November 3, 2023
• Results First Posted: November 3, 2023

Record last verified: 2023-10

Locations

US (1)