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

NCT ID: NCT03383055

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2021-07-10

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.

Conditions

Lymphoma; Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CMV positive cohort

CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT

Group Type: EXPERIMENTAL

CMV-MVA Triplex Vaccine

Intervention Type: BIOLOGICAL

• CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
• TDap administered on Day 56

CMV negative cohort

CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT

Group Type: EXPERIMENTAL

CMV-MVA Triplex Vaccine

Intervention Type: BIOLOGICAL

• CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
• TDap administered on Day 56

Interventions

CMV-MVA Triplex Vaccine

• CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
• TDap administered on Day 56

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Armin Rashidi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Hematology, Oncology and Transplantation Department of Medicine

Locations

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

MT2017-29

Identifier Type: OTHER

Identifier Source: secondary_id

2017LS091

Identifier Type: -

Identifier Source: org_study_id