CMV-CTL for the Treatment of CMV Infection After HSCT

NCT03004261 | Completed Phase 4

• 1 other identifier: CMV-CTL-201609
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). we propose to study the immunologic and virologic effects of donor derived CMV specific cytotoxic T lymphocyte (CMV-CTL) given to transplant recipients CMV antigen peptides will be used to induce the CMV antigen specific T lymphocytes derived from donor peripheral blood mononuclear cells for a period of 18\~21 days.The patients will receive CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The CMV-DNA level will be monitored weekly after transfusion.

Conditions

Cytomegalovirus Infections; Hematological Disease

Keywords

cytomegalovirus infection; cytotoxic T lymphocyte; hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• 30-day response rate

  The percentage of patient whose serum CMV-DNA becomes negative in 30 days.

  from the date of CMV-CTL infusion to 30 days after the infusion

Secondary Outcomes (3)

• 1-year overall survival

  from the date of transplant to 1 year after transplant

• 100-day incidence of acute GVHD

  from the date of transplant to 100 days after transplant

• 1-year incidence of chronic GVHD

  from the date of transplant to 1 year after transplant

Study Arms (1)

CMV-CTL

EXPERIMENTAL

The donor derived cytomegalovirus specific T lymphocytes (CMV-CTL) will be transfused to the patients. The patients will receive CMV-CTL cells when they are sero-positive for CMV-DNA 30 days after transplant. The CMV-DNA levels will be monitored weekly for at least 60 days after the transplant. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive one additional injection of CMV-CTLs. If the CMV levels in the blood continue to rise after the dose of T cells then the patient will receive treatment with Ganciclovir or Foscarnet.

Biological: donor derived cytomegalovirus specific T lymphocytes; Drug: Foscarnet; Drug: Ganciclovir

Interventions

donor derived cytomegalovirus specific T lymphocytes BIOLOGICAL

donor derived cytomegalovirus specific T lymphocytes will be transfused to recipients of hematopoietic stem cell transplant when they are sero-positive for CMV-DNA.

Also known as: cytomegalovirus specific T lymphocytes

CMV-CTL

Foscarnet DRUG

Foscarnet may be used for the treatment of CMV infection before and after the CMV-CTL infusion.

CMV-CTL

Ganciclovir DRUG

Ganciclovir may be used for the treatment of CMV infection before and after CMV-CTL infusion.

CMV-CTL

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Any allogeneic stem cell transplant recipient ≥ 14 years of age and ≤ 60 years of age
• Bilirubin/ SGOT/SGPT \< 5 × upper normal limits.
• Creatinine \< 2 × upper normal limits.
• Ejection fraction ≥ 50%, no severe arrhythmia.
• Estimated life expectancy ≥ 6 months.
• Patients' CMV-DNA ≥ 1000cp/ml in treatment group and being negative in prophylactic group.

You may not qualify if:

• Patients receiving prednisone ≥ 1mg/kg/d for the treatment of acute GVHD or mild, severe chronic GVHD.
• Recipient \< 14years of age
• Donor is sero-positive in HBV/HCV/HIV or RPR.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China: collaborator

Study Sites (1)

Shanghai Jiao Tong University Affilated Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Cytomegalovirus Infections; Hematologic Diseases

Interventions

Foscarnet; Ganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphonoacetic Acid; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Organophosphonates; Organophosphorus Compounds; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Liping Wan, M.D.，Ph.D.

  Shanghai Jiao Tong University Affiliated Shanghai General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 18, 2016
• First Posted: December 28, 2016
• Study Start: November 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)