Cytomegalovirus InfectionsPhase 4NCT03004261
CMV-CTL for the Treatment of CMV Infection After HSCT
A Phase 4 study testing donor derived cytomegalovirus specific T lymphocytes, Foscarnet and Ganciclovir in people with Cytomegalovirus Infections and Hematological Disease, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Cytomegalovirus Infections, Hematological Disease
- What is being tested?
- donor derived cytomegalovirus specific T lymphocytes, Foscarnet and Ganciclovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University Affilated Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
About this study
Official title: Cytomegalovirus Specific Cytotoxic T Lymphocyte for the Treatment of Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation is widely used for the treatment of hematological malignancies and bone marrow failure diseases. Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Approximately half of the recipients would develop CMV infection after transplant. Present treatment recommendation for CMV infection including ganciclovir and foscarnet. However, these medications have many side effects, the most serious is myelosuppression and renal injury, moreover, many patients do not response to these medications. Considering the risk associated with persistent infection and the potential for CMV specific cytotoxic T lymphocyte (CMV-CTL) to restore immunity, we propose to study the immunologic and virologic effects of donor derived CMV-CTL given to transplant recipients, levels of CMV-CTL and CMV DNA will be measured from CTL recipients.
If the patient and their donor are eligible, we will take 80 ml of fresh blood from the donor or 5 ml peripheral blood stem cell from the donor.The peripheral blood mononuclear cells will be separated from peripheral blood or peripheral blood stem cell. CMV antigen peptides will be used to induce the CMV-CTL for a period of 18~21 days.
The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The patients will receive the dose of 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 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, Foscarnet.
- Conditions
- Cytomegalovirus Infections, Hematological Disease
- Being tested
- donor derived cytomegalovirus specific T lymphocytes, Foscarnet, Ganciclovir
- Keywords
- cytomegalovirus infection, cytotoxic T lymphocyte, hematopoietic stem cell transplantation
- Medical subject headings
- Cytomegalovirus Infections, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donor derived cytomegalovirus specific T lymphocytesBiological
Also called cytomegalovirus specific T lymphocytes
donor derived cytomegalovirus specific T lymphocytes will be transfused to recipients of hematopoietic stem cell transplant when they are sero-positive for CMV-DNA.
FoscarnetDrug
Foscarnet may be used for the treatment of CMV infection before and after the CMV-CTL infusion.
GanciclovirDrug
Ganciclovir may be used for the treatment of CMV infection before and after CMV-CTL infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: donor derived cytomegalovirus specific T lymphocytes; Drug: Foscarnet; Drug: Ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day response rate
The percentage of patient whose serum CMV-DNA becomes negative in 30 days.
Measured: from the date of CMV-CTL infusion to 30 days after the infusion
Secondary outcomes (3)
1-year overall survival
The length of patients who are alive in 1 years.
Measured: from the date of transplant to 1 year after transplant
100-day incidence of acute GVHD
the incidence of acute GVHD
Measured: from the date of transplant to 100 days after transplant
1-year incidence of chronic GVHD
the incidence of chronic GVHD
Measured: from the date of transplant to 1 year after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Responsible party
- Principal investigator, Liping Wan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Liping Wan, M.D.，Ph.D., Principal investigator, Shanghai Jiao Tong University Affiliated Shanghai General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004261
- Sponsor's protocol ID
- CMV-CTL-201609
- Status last verified
- Apr 2023
- First submitted
- 18 Dec 2016
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytomegalovirus Specific Cytotoxic T Lymphocyte for the Treatment of Cytomegalovirus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03004261
- Acronym / sponsor ID
- CMV-CTL-201609
- Conditions
- Cytomegalovirus Infections, Hematological Disease
- Keywords
- cytomegalovirus infection, cytotoxic T lymphocyte, hematopoietic stem cell transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Study start
- Nov 2016
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Allogeneic hematopoietic stem cell transplantation is widely used for the treatment of hematological malignancies and bone marrow failure diseases. Human cytomegalovirus (CMV) infection is a major cause of morbidity and mortality for recipients of allogeneic hematopoietic stem cell transplantation(HSCT). Approximately half of the recipients would develop CMV infection after transplant. Present treatment recommendation for CMV infection including ganciclovir and foscarnet. However, these medications have many side effects, the most serious is myelosuppression and renal injury, moreover, many patients do not response to these medications. Considering the risk associated with persistent infection and the potential for CMV specific cytotoxic T lymphocyte (CMV-CTL) to restore immunity, we propose to study the immunologic and virologic effects of donor derived CMV-CTL given to transplant recipients, levels of CMV-CTL and CMV DNA will be measured from CTL recipients.
If the patient and their donor are eligible, we will take 80 ml of fresh blood from the donor or 5 ml peripheral blood stem cell from the donor.The peripheral blood mononuclear cells will be separated from peripheral blood or peripheral blood stem cell. CMV antigen peptides will be used to induce the CMV-CTL for a period of 18~21 days.
The donor derived CMV-CTL cells will be transfused into the patients' intravenous line. The patients will receive the dose of 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 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, Foscarnet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMV-CTL | Experimental | Biological: donor derived cytomegalovirus specific T lymphocytes, Drug: Foscarnet, Drug: GanciclovirThe 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. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| donor derived cytomegalovirus specific T lymphocytesAlso: cytomegalovirus specific T lymphocytesdonor derived cytomegalovirus specific T lymphocytes will be transfused to recipients of hematopoietic stem cell transplant when they are sero-positive for CMV-DNA. | Biological | CMV-CTL |
| FoscarnetFoscarnet may be used for the treatment of CMV infection before and after the CMV-CTL infusion. | Drug | CMV-CTL |
| GanciclovirGanciclovir may be used for the treatment of CMV infection before and after CMV-CTL infusion. | Drug | CMV-CTL |
Primary outcome
30-day response rate
Time frame: from the date of CMV-CTL infusion to 30 days after the infusion
The percentage of patient whose serum CMV-DNA becomes negative in 30 days.
3 secondary outcomes
1-year overall survival
Time frame: from the date of transplant to 1 year after transplant
100-day incidence of acute GVHD
Time frame: from the date of transplant to 100 days after transplant
1-year incidence of chronic GVHD
Time frame: from the date of transplant to 1 year after transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liping Wan, M.D.，Ph.D. principal investigator
Shanghai Jiao Tong University Affiliated Shanghai General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing donor derived cytomegalovirus specific T lymphocytes, Foscarnet and Ganciclovir in people with Cytomegalovirus Infections and Hematological Disease, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day response rate (time frame: from the date of CMV-CTL infusion to 30 days after the infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.