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

Viral Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230356
• Other study ID #: 2019-1217
• Status: Recruiting
• Phase: Phase 2
• Start date: January 27, 2021
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Celeste Dourson, MS
• Phone: 513-636-7679
• Email: Celeste.Dourson[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Allogeneic Stell Cell Transplant
• Communicable Diseases
• Infections
• Viral Infection
• Virus Diseases

Intervention

Biological:
• Viral Specific T-cells (VSTs) Scheduled
VSTs will be infused into stem cell transplant recipients on schedule.
• Viral Specific T-cells (VSTs) Treatment
VSTs will be infused into stem cell transplant recipients only if viremia is detected.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Hoxworth Blood Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	21 - 100 days after transplant