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QUILT-3.035: Relapse Prophylaxis With ALT-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 : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief Summary:
This is a multi-center, phase II clinical trial to prevent relapse using interleukin-15 (IL-15) super-agonist complex (ALT-803) maintenance after allogeneic hematopoietic cell transplantation (alloHCT) in acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: QUILT-3.035: Relapse Prophylaxis With IL-15 Super Agonist ALT-803 in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome Following 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: ALT-803 Drug: ALT-803
ALT-803 6 mcg/kg will be administered subcutaneously once a week on day 1, 8, 15 and 22 followed by 4 weeks of no treatment. Up to 4 treatment cycles (4 weeks on/4 weeks off) are permitted.




Primary Outcome Measures :
  1. 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)


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



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

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 100 post-transplant.
  2. Able to begin study treatment between day +60 and day +100 after the transplant and meets the following transplant related requirements:

    • Sustained neutrophil (ANC > 1000/mcL) and platelet (> 30,000/mcL) engraftment
    • 50% donor chimerism in 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)
    • Ability to be
    • Ability to be treated in the outpatient setting (not an inpatient)
  3. No history of acute GVHD or acute GVHD which is clinically improving in patients who are on topical steroids and/or on low dose systemic steroids (≤ 0.3 mg/kg/day) with clinical stability for at least 1 week prior to determination of eligibility
  4. One of the following donor graft sources:

    • 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 or SGPT < 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. Pregnant or breastfeeding - ALT-803 is an investigational agent. Women of child bearing potential must have a negative pregnancy test at screening.
  2. 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)
  3. Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
  4. Active uncontrolled bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy.
  5. Active autoimmune disease requiring immunosuppressive therapy
  6. History of severe asthma and currently on chronic medications (mild asthma requiring inhaled steroids only is eligible)
  7. Received any investigational agent within the 14 days before the start of study treatment (1st dose of ALT-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 ClinicalTrials.gov identifier (NCT number): NCT02989844


Locations
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Celalettin Ustun, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT02989844     History of Changes
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: October 22, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Leukemia
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions