A multi-center randomized phase II study of nutritonal support with intensive glucose control after allogeneic stem cell transplantation lipid-free vs lipid

A multi-center randomized phase II study of nutritonal support with intensive glucose control after allogeneic stem cell transplantation lipid-free vs lipid - NST01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001189

Enrollment

Registered

2008-06-16

Start date

2007-06-01

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

hematological malignancies

Interventions

Intensive Glucose control Use of intravenous lipid formulation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hematological malignancies who will benefit from allogeneic stem cell transplantation with myeloablative conditioining regimen

Exclusion criteria

Exclusion criteria: (1) CML blast crisis (2) chemotherapy-refractory ML or ATLL (3) Patient who has already received multiple allogeneic stem cell transplantation (4) Patient with active infection (5) Patient with uncontrolled CNS invasion (6) Hypertriglyceridemia (>350 mg/dL) (7) Patient with DM and with insulin therapy (8) Patient who are pregnant (9) Patient with mental disorder (10) Patient with allergy to drugs which are included in conditioning regimen or GVHD prophylaxis (11) Patient with allergy to intravenous lipid formulation or insulin

Design outcomes

Primary

Measure	Time frame
Documented infections at 100 days post-transplant	—

Secondary

Measure	Time frame
secondary endpoint 1.Overall survival and progression-free survival at 100 days post-transplant 2.Overall survival and progression-free survival at 1 year post-trasnplant 3.treatment-related toxicity(CTCAE ver.3.0) 4.probability and severity of GVHD 5.time to GVHD 6.time to engraftment 7.probability of engraftment 8.insulin dose 9.hyperglycemia and hypoglycemia(CTCAE ver.3.0)	—

Countries

Japan

Contacts

Public ContactShinobu Saito

National Cancer Center Hospital Data Center

shsaito@ncc.go.jp03-3542-2511

Outcome results

None listed

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