Evaluation of CMV/EBV-CMI in Haploid HSCT

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-60
SponsorThe First Affiliated Hospital of Soochow University

About this trial

The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients were diagnosed with hemopathy.

All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.

All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.

Disqualifiers

None

Trial population

Patients are diagnosed with hemopathy and should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CMV/EBV-CMI

    Diagnostic test

    The CMV/EBV-CMI is tested before conditioning regimen and 30 days, 45 days, 60 days, 90 days, 120 days, 180 days after transplantation.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

CMV-CMI

CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT

Time frame
6 months after transplantation
2

EBV-CMI

EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT

Time frame
6 months after transplantation

Secondary outcomes

1

Cumulative incidence of CMV reactivation

The cumulative incidences of CMV reactivation after transplantation.

Time frame
1 years after transplantation
2

Cumulative incidences of EBV reactivation

The cumulative incidences of EBV reactivation after transplantation

Time frame
1 years after transplantation
3

Overall survival (OS)

Overall survival (OS) is defined as the time from randomization to death resulting from any cause.

Time frame
1 years after transplantation
4

Non-relapse mortality (NRM)

Non-relapse mortality (NRM) is defined as the time from enrollment to death of any causes other than hematologic disease relapse.

Time frame
1 years after transplantation

Other outcomes

Sponsors and contacts

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