Phase I study of CMV specific CTL for treatment of refractory CMV infection after allogeneic hematopoietic stem cell transplantation

Phase I study of CMV specific CTL for treatment of refractory CMV infection after allogeneic hematopoietic stem cell transplantation - Phase I study of CMV specific CTL for treatment of refractory CMV infection after allogeneic hematopoietic stem cell transplantation

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001749

Enrollment

Registered

2009-03-03

Start date

2009-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory CMV infection after allogeneic hematopoietic stem cell transplantation

Interventions

Administration of CMV specific CTL induced and expanded from donor peripheral blood

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. CMV infection resistant to ganciclovir and/or foscarnet after allogeneic hematopoietic stem cell transplantation 2. Fulfill all of the following criteria: Performance status 0-3, GOT /GPT =< 20 x upper normal limit, total bilirubin < 6 mg/dl, serum creatinine =< 3 x upper normal limit, PaO2 >= 60mmHg, PaCO2 =< 60mmHg, No evidence of heart failure, Ejection Fraction >= 50% 3. Written informed consent from patient or person in parental authority 4. donor peripheral blood available

Exclusion criteria

Exclusion criteria: 1. Severe or uncontrollable bacterial, fungal, and viral (except CMV) infection 2. Uncontrollable acute and chronic GVHD 3. Psychoses 4. History of allergic reaction to albumin

Design outcomes

Primary

Measure	Time frame
Adverse events	—

Secondary

Measure	Time frame
Monitoring of CMV reactivation (quantitative PCR and CMV antigenemia) and CMV specific CTL in peripheral blood	—

Countries

Japan

Contacts

Public ContactYoshiyuki Takahashi

Nagoya University Graduate School of Medcine Department of Pediatrics

ytakaha@med.nagoya-u.ac.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026