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CMV-MVA Triplex Vac.Enhance Adap. NK Cell Recon. After Auto HSCT in pt Lymphoid Malig

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ClinicalTrials.gov Identifier: NCT03383055
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief Summary:
This is a single-arm, prospective, interventional study administering 2 doses of the experimental vaccine (CMV-MVA Triplex) to 20 evaluable patients (10 CMV-seropositive and 10 seronegative) undergoing autologous hematopoietic cell transplantation (HCT) for lymphoma or myeloma on days 28 and 56 post-HCT. The absolute number of adaptive NK cells (CD56dimCD57+NKG2C+) at various days will be compared.

Condition or disease Intervention/treatment Phase
Lymphoma Multiple Myeloma Biological: CMV-MVA Triplex Vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CMV-MVA Triplex Vaccine to Enhance Adaptive NK Cell Reconstitution After Autologous Hematopoietic Cell Transplantation in Patients With Lymphoid Malignancies
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: CMV-MVA Triplex Biological: CMV-MVA Triplex Vaccine
  • CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
  • TDap administered on Day 56




Primary Outcome Measures :
  1. Change in the absolute number of CMV-induced adaptive NK cells (CD56dimCD57+NKG2C+) between days 28 and 100 post-auto-HCT in patients with lymphoid malignancies. [ Time Frame: Day 28 and Day 100 ]
    Change in the absolute number of CMV-induced adaptive NK cells (CD56dimCD57+NKG2C+) on day 28 (pre first vaccine) and day 100 (~1 month after second vaccine) post-auto- HCT in patients with lymphoid malignancies.


Secondary Outcome Measures :
  1. Change in absolute Number of CMV-induced adaptive NK Cells [ Time Frame: Day 28 and Day 100 ]
    Change in absolute number of total NK and NK/T cells between days 28 (first vaccine) and day 100 (~1 month after second vaccine) post-auto-HCT in patients with lymphoid malignancies (lymphoma and myeloma).

  2. Response to CMV-MVA Triplex vaccine in CMV seropositive vs. seronegative patients [ Time Frame: Day 28 and Day 100 ]
    Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100.

  3. Progression Free Survival (PFS) [ Time Frame: 1 Year ]
    Incidence of progression-free survival at 1 year in patients receiving CMV-MVA Triplex vaccine with historical controls

  4. Response to CMV-MVA Triplex vaccine in lymphoma vs. myeloma patients [ Time Frame: Day 28 and Day 100 ]
    Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Lymphoma or multiple myeloma
  • Planned co-enrollment on current (at the time of this study version) or future (opening subsequent to this study) standard of care autologous stem cell transplant protocol.

    * Must meet all eligibility requirements of the co-enrolled parent study

  • Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control until at least day 100 post-HCT
  • Voluntary written consent signed before performance of any study-related procedure not part of normal medical care

Exclusion Criteria:

  • CMV immunoglobulin, valganciclovir, ganciclovir, foscarnet, or other anti-CMV therapy within 3 months before the first vaccine is planned. Acyclovir and valacyclovir are allowed.
  • Pregnant or breast feeding. The FDA has not classified this agent into a specified pregnancy category. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
  • Planned immunotherapy post-HCT. Lenalidomide and/or proteasome inhibitors are allowed in myeloma patients.

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): NCT03383055


Contacts
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Contact: Armin Rashidi, MD, PhD 612-625-9604 arashidi@umn.edu

Locations
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United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Armin Rashidi, MD, PhD    612-625-9604    arashidi@umn.edu   
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
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Principal Investigator: Armin Rashidi, MD, PhD University of Minnesota Hematology, Oncology and Transplantation Department of Medicine

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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT03383055     History of Changes
Other Study ID Numbers: 2017LS091
MT2017-29 ( Other Identifier: University of Minnesota Masonic Cancer Center )
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs