CMV-MVA Triplex Vac.Enhance Adap. NK Cell Recon. After Auto HSCT in pt Lymphoid Malig
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | November 16, 2018 |
| End Date: | August 2020 |
| Contact: | Armin Rashidi, MD, PhD |
| Email: | arashidi@umn.edu |
| Phone: | 612-625-9604 |
CMV-MVA Triplex Vaccine to Enhance Adaptive NK Cell Reconstitution After Autologous Hematopoietic Cell Transplantation in Patients With Lymphoid Malignancies
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.
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.
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.
We found this trial at
1
site
425 E River Pkwy # 754
Minneapolis, Minnesota 55455
Minneapolis, Minnesota 55455
612-624-2620
Phone: 612-625-9604
Masonic Cancer Center at University of Minnesota The Masonic Cancer Center was founded in 1991....
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