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Virus Therapy

Treated Donor Lymphocytes for Cytomegalovirus

Phase 1

Waitlist Available

Led By Kenneth G. Lucas, MD

Research Sponsored by Milton S. Hershey Medical Center

Eligibility Criteria Checklist

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

Must have

Recipient of an allogeneic stem cell transplantation

Cytomegalovirus (CMV)-seropositive with history of CMV antigenemia for ≥ 2 weeks or CMV DNA levels ≥ 600 copies/mcg of DNA despite antiviral therapy targeting CMV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing if white blood cells that have been treated in the lab can kill cells infected with cytomegalovirus.

Who is the study for?

This trial is for patients who've had a donor stem cell transplant and are now dealing with cytomegalovirus infections. They should be in fair to good health otherwise, with acceptable blood, liver, and kidney function tests. It's not for those extremely ill or on high doses of steroids.Check my eligibility

What is being tested?

The study is testing specially treated white blood cells called cytotoxic T cells to see if they can fight off the cytomegalovirus infection in patients who have received a stem cell transplant from a donor.See study design

What are the potential side effects?

While specific side effects aren't listed here, treatments involving immune cells like cytotoxic T lymphocytes could potentially cause reactions such as fever, chills, fatigue, headache or more serious complications related to immune response.

Eligibility Criteria

Inclusion Criteria

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

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I have received a stem cell transplant from a donor.

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I have had a CMV infection that didn't improve with treatment.

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I have a donor for cell collection who is either CMV positive or a CMV negative adult willing to get vaccinated.

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I do not have ongoing graft-vs-host disease.

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I can care for myself but may not be able to do active work or play.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety

Toxicity

Secondary outcome measures

CMV DNA levels

Feasibility of CMV pp65- and IE-1 CTL culture after CMV vaccination of seronegative donors

Time during post-infusion follow-up at which the dominant CMV pp65- and IE-1 epitopes for the donor is recognized by the cytotoxic T-cell lymphocytes (CTL)

+1 more

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

492 Previous Clinical Trials

2,798,802 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,133 Total Patients Enrolled

Kenneth G. Lucas, MDPrincipal InvestigatorMilton S. Hershey Medical Center

9 Previous Clinical Trials

87 Total Patients Enrolled

Media Library

Donor Lymphocytes (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00769613 — Phase 1

Cancer Clinical Trial 2023: Donor Lymphocytes Highlights & Side Effects. Trial Name: NCT00769613 — Phase 1

Donor Lymphocytes (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00769613 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential adverse effects associated with this treatment?

"This medical intervention's safety score was determined to be 1 as it is a Phase 1 trial, meaning there are minimal supportive data for both efficacy and safety."

Answered by AI

Is enrollment currently open for this experiment?

"The clinicaltrials.gov website reports that this particular study is not presently recruiting participants, as the posting went live on August 1st 2008 and was most recently updated December 17th 2013. Nevertheless, 1455 other trials are looking for volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections

2008. "Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00769613.

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