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Virus Therapy

Triplex Vaccine for CMV Prevention Post-Stem Cell Transplant

Phase 2

Waitlist Available

Led By Ryotaro Nakamura

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase

Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease

Must not have

Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible

Poor risk disease/disease status including: chronic myeloid leukemia (CML) in blast crisis, acute myeloid leukemia (AML)/acute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 100 to day 180 post-hematopoietic stem cell transplant (hct)

Summary

This trial will study how well the Triplex vaccine works in preventing CMV infection in patients undergoing a hematopoietic stem cell transplantation.

Who is the study for?

This trial is for patients with certain blood cancers like leukemia and lymphoma, who are undergoing stem cell transplantation and are at risk of CMV infection. They must be CMV positive, agree to use contraception, and not have received any prior investigational CMV vaccines or treatments that could affect the immune system.

What is being tested?

The study tests the Triplex vaccine's effectiveness in preventing CMV infection post-stem cell transplant. The vaccine contains three pieces of CMV DNA within a weakened virus to stimulate immunity against this potentially harmful virus in immunocompromised individuals.

What are the potential side effects?

Potential side effects may include typical vaccine reactions such as soreness at injection site, fever, fatigue, muscle pain. Since it involves genetic material within a weakened virus vector, there might also be risks related to immune responses or interaction with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia is in an early or slightly advanced stage.

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I do not have HIV, hepatitis C, active hepatitis B, or widespread HPV-related skin disease.

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I am scheduled for a stem cell transplant with minimal T-cell removal.

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I have been diagnosed with lymphoma.

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I am scheduled for a stem cell transplant with a half-matched donor.

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I am scheduled for a stem cell or bone marrow transplant for blood cancer treatment.

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My acute myeloid leukemia is in the first or second remission.

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I have been diagnosed with myelodysplastic syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken immunosuppressive drugs for an autoimmune disease in the last 5 years.

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My condition is advanced and includes CML in blast crisis, AML/ALL beyond 2nd remission, multiple myeloma, or aplastic anemia.

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I have undergone specific treatments within 30 days before or up to 180 days after a stem cell transplant.

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I am not in any other clinical trials with new drugs from the time of my transplant to 70 days after.

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I haven't received T-cell depleting agents or CD34+ selection from HCT to 70 days after.

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I am receiving allergy shots from the time of my cell transplant until 70 days after.

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I am taking antiviral medication that works against CMV, except for acyclovir.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 100 to day 180 post-hematopoietic stem cell transplant (hct)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 100 to day 180 post-hematopoietic stem cell transplant (hct)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 100 to day 180 post-hematopoietic stem cell transplant (hct) for reporting.