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Foscarnet therapy (90 mg/kg) to prevent HHV-6 encephalitis in umbilical cord blood transplant recipients

Foscarnet therapy (90 mg/kg) to prevent HHV-6 encephalitis in umbilical cord blood transplant recipients - Foscarnet to prevent HHV-6 encephalitis for CBT recipients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014073
Enrollment
50
Registered
2014-06-01
Start date
2014-11-15
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

The patients 16 years or older who receive umbilical cord blood transplant as the first allogeneic hematopoietic cell transplantation for the treatment of hematologic malignancies (blood cancers) .

Interventions

Foscarnet administration

Sponsors

Research team to establish the efficacy of allogeneic stem cell transplantation for adult T cell leukemia, and optimize the treatment based on genome analysis. JSHCT
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who receive umbilical cord blood transplantation as the first allogeneic stem cell transplantation for the treatment of hematologic malignancies (blood cancers). 2. Patient 16 years or older. 3. Written informed consent. If patient is less than 20 years, written informed consent from both patient and patient's parent/guardian is required.

Exclusion criteria

Exclusion criteria: 1. Patient who have allergy against foscarnet. 2. Patient whose creatinine clearance <0.8 mL/min/kg 3. Patient who is judged as inappropriate to participate this study by any reasons. Medical doctor participating this study make this decision.

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of plasma HHV-6 DNA>=10,000 copies/ml at 60 days after transplantation.

Secondary

MeasureTime frame
1. Safety 2. Incidence of HHV-6 encephalitis and possible HHV-6 encephalitis within 60 days after transplantation 3. Overall survival at 60 days after transplantation 4. Cumulative incidence of non-repapse mortality, relapse, acute GVHD 5. Relationship between HHV-6 reactivation and administration period of foscarnet 6. Incidence of plasma HHV-6 DNA>=10,000 copies/ml in patients who complete 21 days administration of foscarnet.

Countries

Japan

Contacts

Public ContactMasaaki Kurihara

Non-profit organization Japan Clinical research Support Unit Research support section for Pediatrics/Hematology

Info@crsu.org03-5297-6258

Outcome results

None listed

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