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Dexamethasone, ifosfamide, carboplatin, and etoposide in treating patients with refractory lymphoblastic lymphoma.

Dexamethasone, ifosfamide, carboplatin, and etoposide in treating patients with refractory lymphoblastic lymphoma. - DexICE therapy for refractory LBL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016346
Enrollment
24
Registered
2015-02-14
Start date
2015-02-16
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

Lymphoblastic lymphoma

Interventions

Vertification of efficacy and safety of dexamethasone, ifosfamide, carboplatin, and etoposide in treating patients with refractory or first relapsed lymphoblastic lymphoma.

Sponsors

Japan children's cancer group.
Lead Sponsor
Japan Society for the Promotion of Science
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Lymphoblastic lymphoma according to 2007 WHO classification through pathological assay. 2) Progressive or recurrent stage III/IV disease without central nervous infiltration. 3) Above 1-year old at initial diagnosis and under 20-year old at registry. 4) Adequate organ function with meeting safety laboratory criteria those listed following, excluding conditions caused by a tumor. Total bilirubin below 3.1 mg/dl. Serum creatinine level below 0.81 mg/dl(under 5-year old), Below 1.21 (5-9 year) Below 1.5 (above 9 year) Without arrhythmia and QT prolongation under medication. Ejection fraction above 49% and fractional shortening above 24% in echocardiogram of heart. 5) Agreement by a document for participation of this clinical trial.

Exclusion criteria

Exclusion criteria: 1) Down syndrome. 2) Existence of CNS infiltration. 3) Philadelphia chromosome positive disease. 4) Myelodysplastic syndromes. 5) Other previous illness of malignant tumor. 6) Previous therapy of organ transplantation including blood stem cells. 7) Previous illness of congenital and HIV related immunodeficiency. 8) Additional status that a doctor in charge judges to be improper.

Design outcomes

Primary

MeasureTime frame
Complete and partial remission rate.

Secondary

MeasureTime frame
Event free and overall survival at 2-year. Proportion of adverse events and attainment rate for allogeneic blood stem cell transplantation. Searching for correlation between minimal marrow and blood disseminated disease with prognosis. Searching for specific tumor gene character in refractory LBL through gene profiling assay.

Countries

Japan

Contacts

Public ContactTetsuo Mitsui

Yamagata University Hospital Pediatrics

tmitsui@med.id.yamagata-u.ac.jp023-628-5329

Outcome results

None listed

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