Clinical trial NCT03383055: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Multiple Myeloma
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: Day 28 and Day 100
Secondary outcomes:
measure: Change in absolute Number of CMV-induced adaptive NK Cells
timeFrame: Day 28 and Day 100
measure: Response to CMV-MVA Triplex vaccine in CMV seropositive vs. seronegative patients
timeFrame: Day 28 and Day 100
measure: Progression Free Survival (PFS)
timeFrame: 1 Year
measure: Response to CMV-MVA Triplex vaccine in lymphoma vs. myeloma patients
timeFrame: Day 28 and Day 100
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota Hematology, Oncology and Transplantation Department of Medicine
name: Armin Rashidi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: