CMV-Specific T Cells for prevention of CMV Reactivation After Allogeneic Stem Cell Transplantation.

Phase 1

Recruiting

• Conditions: Allogeneic stem cells transplantation.; Stem cells transplant status; Z94.84

• Registration Number: IRCT20140818018842N30
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Allogeneic stem cell transplantation recipient
Age >=??
CMV seropositive donor

Exclusion Criteria

Unrelated donor
Participation in other clinical trials

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of Patients With Grades 3-5 of cytotoxic T-cell infusion-related Adverse Events (Version 4.03). Timepoint: Daily during the seven days after the injection. Method of measurement: Physical exam, history and lab tests.;Cytomegalovirus reactivation. Timepoint: Weekly intervals until three months after the T-cell injection. Method of measurement: RT-PCR in the peripheral blood to assess Cytomegalovirus-DNA.

Secondary Outcome Measures

Name	Time	Method
Prolonged cytopenia. Timepoint: Daily during the first seven days after the injection and then weekly until one-month after the injection. Method of measurement: Complete peripheral blood cell count.;Acute Graft versus Host Disease. Timepoint: Weekly interval until 100 days post-transplantation. Method of measurement: physical exam, lab test, and biopsy.