Back to resultsCMV-MVA Triplex Vac.Enhance Adap. NK Cell Recon. After Auto HSCT in pt Lymphoid Malig
Primary Purpose
Lymphoma, Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CMV-MVA Triplex Vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility 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. Proteasome inhibitors and/or immunomodulators, such as but not limited to Lenalidomide or Pomalidomide, used for myeloma maintenance are allowed.
Sites / Locations
- Masonic Cancer Center at University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CMV positive cohort
CMV negative cohort
Arm Description
CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
Outcomes
Primary Outcome Measures
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.
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
Change in absolute Number of CMV-induced adaptive NK Cells
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).
Response to CMV-MVA Triplex vaccine in CMV seropositive vs. seronegative patients
Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100.
Progression Free Survival (PFS)
Incidence of progression-free survival at 1 year in patients receiving CMV-MVA Triplex vaccine with historical controls
Response to CMV-MVA Triplex vaccine in lymphoma vs. myeloma patients
Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100.
Full Information
NCT ID
NCT03383055
First Posted
December 11, 2017
Last Updated
August 11, 2021
Sponsor
Masonic Cancer Center, University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03383055
Brief Title
CMV-MVA Triplex Vac.Enhance Adap. NK Cell Recon. After Auto HSCT in pt Lymphoid Malig
Official Title
CMV-MVA Triplex Vaccine to Enhance Adaptive NK Cell Reconstitution After Autologous Hematopoietic Cell Transplantation in Patients With Lymphoid Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2018 (Actual)
Primary Completion Date
July 10, 2021 (Actual)
Study Completion Date
July 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
4. Oversight
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
5. Study Description
Brief Summary
This is a 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CMV positive cohort
Arm Type
Experimental
Arm Description
CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
Arm Title
CMV negative cohort
Arm Type
Experimental
Arm Description
CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
Intervention Type
Biological
Intervention Name(s)
CMV-MVA Triplex Vaccine
Intervention Description
CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
TDap administered on Day 56
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Day 28 and Day 100
Secondary Outcome Measure Information:
Title
Change in absolute Number of CMV-induced adaptive NK Cells
Description
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).
Time Frame
Day 28 and Day 100
Title
Response to CMV-MVA Triplex vaccine in CMV seropositive vs. seronegative patients
Description
Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100.
Time Frame
Day 28 and Day 100
Title
Progression Free Survival (PFS)
Description
Incidence of progression-free survival at 1 year in patients receiving CMV-MVA Triplex vaccine with historical controls
Time Frame
1 Year
Title
Response to CMV-MVA Triplex vaccine in lymphoma vs. myeloma patients
Description
Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100.
Time Frame
Day 28 and Day 100
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. Proteasome inhibitors and/or immunomodulators, such as but not limited to Lenalidomide or Pomalidomide, used for myeloma maintenance are allowed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin Rashidi, MD, PhD
Organizational Affiliation
University of Minnesota Hematology, Oncology and Transplantation Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CMV-MVA Triplex Vac.Enhance Adap. NK Cell Recon. After Auto HSCT in pt Lymphoid Malig
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