Active — Not RecruitingPhase 1

CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant

United States34 participantsStarted 2018-08-20

Plain-language summary

This phase II trial studies how well multi-peptide CMV-modified vaccinia Ankara (CMV-MVA Triplex) vaccination of stem cell donors works in preventing cytomegalovirus (CMV) viremia in participants with blood cancer undergoing donor stem cell transplant. Giving a vaccine to the donors may boost the recipient's immunity to this virus and reduce the chance of CMV disease after transplant.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * DONOR: Ability to comprehend the investigational nature of the study and provide informed consent * DONOR: Willing to receive Triplex vaccination, a minimum of 14 days prior to the PBSC collection * DONOR VACCINATION: Donors are eligible to be vaccinated prior to the determination of their human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and human T-cell lymphotropic virus (HTLV) status. The exclusion criteria for transplant is independent of eligibility for vaccination and is determined by the exclusion criteria for transplant from donors * RECIPIENT: All subjects must have the ability to understand and the willingness to sign a written informed consent * RECIPIENT: Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT * RECIPIENT: Age 18 to 75 years * RECIPIENT: Planned HCT for the treatment of the following hematologic malignancies: lymphoma (Hodgkin and non-Hodgkin), myelodysplastic syndrome, acute lymphoblastic leukemia in first or second remission, acute myeloid leukemia in first or second remission, chronic myelogenous leukemia (in first chronic or accelerated phase, or in second chronic phase), chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis (City of Hope \[COH\] only). Patients with multiple myeloma are excluded * RECIPIENT: CMV seropositive * RECIPIENT: Planned related HCT with 8/8 (A, B, C, DRB1) …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Delayed Engraftment

Timeframe: Up to 1 year from stem cell infusion.

Severe (Grade III-IV) Acute Graft Versus Host Disease

Timeframe: Up to 6 months from stem cell infusion

Number of Recipients With Grade 3-4 Adverse Events

Timeframe: Up to 1 year from stem cell infusion.

Number of Donors With Grade 2-3 Adverse Events

Timeframe: Up to 6 months after G-CSF mobilization

100-Day Non-Relapse Mortality (NRM)

Timeframe: From stem cell infusion up to 100 days post-HSCT (hematopoietic stem cell transplantation).

Trial details

NCT IDNCT03560752

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-22

Results submitted2023-12-20

View on ClinicalTrials.gov More Accelerated Phase CML, BCR-ABL1 Positive trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Delayed Engraftment

Timeframe: Up to 1 year from stem cell infusion.

Severe (Grade III-IV) Acute Graft Versus Host Disease

Timeframe: Up to 6 months from stem cell infusion

Number of Recipients With Grade 3-4 Adverse Events

Timeframe: Up to 1 year from stem cell infusion.

Number of Donors With Grade 2-3 Adverse Events

Timeframe: Up to 6 months after G-CSF mobilization

100-Day Non-Relapse Mortality (NRM)

Timeframe: From stem cell infusion up to 100 days post-HSCT (hematopoietic stem cell transplantation).