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Virus Therapy

CMV-Specific T-Cells for Cytomegalovirus Infection

Phase 2

Waitlist Available

Led By Betul Oran

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Optimum therapy is defined as at least 14 days of therapy with ganciclovir, foscarnet, cidofovir, or valganciclovir for patients with disease or CMV viremia

Clinical status at enrollment to allow tapering of steroids equal to or less than 0.5 mg/kg/day of prednisone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial looks at whether white blood cells from donors who have been exposed to cytomegalovirus can help treat patients with a cytomegalovirus infection that has come back or has not gotten better despite standard therapy.

Who is the study for?

This trial is for patients with persistent or recurrent cytomegalovirus (CMV) infection despite standard therapy, including those who can't tolerate such treatments due to side effects. Eligible participants may have blood cancers, tumors, or be immunocompromised. They must not have acute graft-versus-host disease grades II-IV or other uncontrolled infections.Check my eligibility

What is being tested?

The trial tests whether white blood cells from donors previously exposed to CMV can effectively treat patients with CMV infections that haven't improved after standard antiviral therapies like ganciclovir and foscarnet.See study design

What are the potential side effects?

Potential side effects include immune reactions as the body adjusts to donor T-cells, which could lead to symptoms similar to flu-like illnesses, fatigue, rash, fever and potential complications in organs where CMV was present.

Eligibility Criteria

Inclusion Criteria

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

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I have been treated for CMV with specific medications for at least 14 days.

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I am on a low dose of steroids, 0.5 mg/kg/day or less.

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My antiviral treatment for CMV didn't lower the virus levels in my blood.

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My CMV infection hasn't improved despite treatment.

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I have CMV disease confirmed by tests on lung fluid or tissue samples.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Success, defined as R1 and R2 without treatment failure

Secondary outcome measures

Disease-free survival time

Graft-versus-host disease

Overall survival time

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (allogeneic CMV-specific cytotoxic T-lymphocytes)Experimental Treatment1 Intervention

Patients receive allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes IV. Patients with partial response, stable disease, or progressive disease may receive an additional dose of allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes at a minimum of 2 weeks from the first infusion.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,618 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,753 Total Patients Enrolled

Betul OranPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

180 Total Patients Enrolled

Media Library

Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02210078 — Phase 2

Cytomegalovirus Research Study Groups: Treatment (allogeneic CMV-specific cytotoxic T-lymphocytes)

Cytomegalovirus Clinical Trial 2023: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes Highlights & Side Effects. Trial Name: NCT02210078 — Phase 2

Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02210078 — Phase 2

Frequently Asked Questions

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

What is the total number of participants that will be enrolled in this experiment?

"That is accurate. The information on clinicaltrials.gov shows that this trial is currently looking for 50 participants at 1 site. This study was first posted on February 19th, 2015 and was updated most recently on October 27th, 2020."

Answered by AI

Does the FDA recognize Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes as a safe and effective treatment?

"While there is some data supporting the safety of Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes, it received a score of 2 because there is no efficacy data at this time."

Answered by AI

Are there any current vacancies for this research project?

"The clinicaltrials.gov website indicates that this study is still recruiting patients. The original posting date was February 19th, 2015 with the most recent edit taking place on October 27th, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Donor Cytomegalovirus-Specific Cytotoxic T-Lymphocytes in Treating Patients With a Persistent Cytomegalovirus Infection

2015. "Donor Cytomegalovirus-Specific Cytotoxic T-Lymphocytes in Treating Patients With a Persistent Cytomegalovirus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02210078.

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