Back to results

Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant

Primary Purpose

Allogeneic Stell Cell Transplant, Viral Infection

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Viral Specific T-cells (VSTs) Scheduled

Viral Specific T-cells (VSTs) Treatment

About this trial

This is an interventional other trial for Allogeneic Stell Cell Transplant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

SCHEDULED ARM:

Inclusion Criteria:

Recipient must be at least 21 days after stem cell infusion
Clinical status must allow tapering of any steroids to < 0.5mg/kg prednisone or other steroid equivalent
No critical illness making VST infusion hazardous

Exclusion Criteria:

Active acute GVHD grades II-IV.
Uncontrolled relapse of malignancy.
Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their conditioning regimen. The level must be less than or equal to 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for scheduled VST infusion at that point.

TREATMENT ARM

Inclusion Criteria:

Blood adenovirus PCR ≥1,000
Blood CMV PCR ≥ 500
Blood EBV PCR ≥ 9,000
Plasma BKV PCR >1,000
Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx.
Evidence of invasive CMV infection, defined as pneumonitis, retinitis, colitis, hepatitis
Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation.
Evidence of symptomatic BK virus infection, defined as hemorrhagic cystitis or BK nephropathy.
No active acute GVHD grades II-IV
No uncontrolled relapse of malignancy
No infusion of ATG or alemtuzumab within 2 weeks of VST infusion.
Clinical status must allow tapering of any steroids to < 0.5mg/kg prednisone or other steroid equivalent

Sites / Locations

Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

VSTs to Prevent

VSTs to Treat

Arm Description

VSTs are given through an IV infusion 21 days after transplant to see if the VSTs will help prevent a viral infection.

VSTs will be given only if a viral infection develops.

Outcomes

Primary Outcome Measures

Number of Treatment Failures

Treatment failure is defined as EBV>100,000, BKV >100,000, CMV >5,000 or Adv >50,000 at any time post randomization.

Secondary Outcome Measures

Full Information

NCT ID

NCT04230356

First Posted

January 13, 2020

Last Updated

February 22, 2023

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Hoxworth Blood Center

1. Study Identification

Unique Protocol Identification Number

NCT04230356

Brief Title

Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant

Official Title

A Randomized Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells (VSTs) for Control of Viral Infections After Allogeneic Stem Cell Transplant

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 27, 2021 (Actual)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Hoxworth Blood Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent or treat viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. VSTs are cells specially designed to fight viral infections that may happen after a stem cell transplant (SCT). Stem cell transplant reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find a better way to treat these infections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allogeneic Stell Cell Transplant, Viral Infection

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VSTs to Prevent

Arm Type

Experimental

Arm Description

VSTs are given through an IV infusion 21 days after transplant to see if the VSTs will help prevent a viral infection.

Arm Title

VSTs to Treat

Arm Type

Experimental

Arm Description

VSTs will be given only if a viral infection develops.

Intervention Type

Biological

Intervention Name(s)

Viral Specific T-cells (VSTs) Scheduled

Intervention Description

VSTs will be infused into stem cell transplant recipients on schedule.

Intervention Type

Biological

Intervention Name(s)

Viral Specific T-cells (VSTs) Treatment

Intervention Description

VSTs will be infused into stem cell transplant recipients only if viremia is detected.

Primary Outcome Measure Information:

Title

Number of Treatment Failures

Description

Treatment failure is defined as EBV>100,000, BKV >100,000, CMV >5,000 or Adv >50,000 at any time post randomization.

Time Frame

21 - 100 days after transplant

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

SCHEDULED ARM: Inclusion Criteria: Recipient must be at least 21 days after stem cell infusion Clinical status must allow tapering of any steroids to < 0.5mg/kg prednisone or other steroid equivalent No critical illness making VST infusion hazardous Exclusion Criteria: Active acute GVHD grades II-IV. Uncontrolled relapse of malignancy. Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their conditioning regimen. The level must be less than or equal to 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for scheduled VST infusion at that point. TREATMENT ARM Inclusion Criteria: Blood adenovirus PCR ≥1,000 Blood CMV PCR ≥ 500 Blood EBV PCR ≥ 9,000 Plasma BKV PCR >1,000 Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx. Evidence of invasive CMV infection, defined as pneumonitis, retinitis, colitis, hepatitis Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation. Evidence of symptomatic BK virus infection, defined as hemorrhagic cystitis or BK nephropathy. No active acute GVHD grades II-IV No uncontrolled relapse of malignancy No infusion of ATG or alemtuzumab within 2 weeks of VST infusion. Clinical status must allow tapering of any steroids to < 0.5mg/kg prednisone or other steroid equivalent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Celeste Dourson, MS

Phone

513-636-7679

Celeste.Dourson@cchmc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Jamie Wilhelm, BS

Phone

513-803-1102

Jamie.Wilhelm@cchmc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stella Davies, MBBS, PhD

Organizational Affiliation

Children's Hospital Medical Center, Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Celeste Dourson, MS

Phone

513-636-7679

Celeste.Dourson@cchmc.org

First Name & Middle Initial & Last Name & Degree

Stella Davies, MBBS, PhD

12. IPD Sharing Statement

Learn more about this trial

Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant

We'll reach out to this number within 24 hrs