lymphoblastic lymphoma stage III / IV
Conditions
Interventions
Patients under 20 years old and diagnosed as stage III / IV lymphoblastic lymphoma are enrolled in this study and are treated with one of standard chemotherapy regimen NHL-BFM95.
Sponsors
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) diagnosis of precursor T-cell lymphoblastic lymphoma or precursor B-cell lymphoblastic lymphoma (ratio of blast in bone marrow is less than 25%) (2) diagnosis of stage III/IV disease (3) age under 20 year old at diagnosis (4) registration at JPLSG CHM-14 study (5) no history of previous anti-cancer therapy except listed below ; a) biopsy or surgical resection b) emergency irradiation therapy within 7days c) prednisolone therapy within 7 days d) VCR or DNR therapy within 7 days in order to improve severe dyspnea (6) ECOG performance status (PS) score of 0-2, or worsening to 4 due to lymphoma (7) sufficient hepatic and renal function satisfying the laboratory data listed below ; a) T-Bili: within 3x of age adjusted upper-limit of normal range. b) Creatinine: within 3x of age adjusted upper-limit of normal range. (8) observation for at least 3 years after biginning treatment (9) written informed consent obtained from patient or guardians.
Exclusion criteria
Exclusion criteria: (1) Down syndrome. (2) Other previous illness of malignant tumor or previous therapy of organ transplantation including hematopoietc stem cells. (3) history of congenital or acquired immunodeficiency. (4) uncontrolled infection, including active tuberculosis infection and positive of HIV antibody. (5) pregnancy or high possibility of pregnancy and giving suck woman. (6) QTfc, corrected by Friderics formula as QTfc = QT/RR*1/3, is more than 0.45 seconds. (7) CNS hemorrage more than grade 3 of CACAE v4.0 (8) MDS, Ph1 positive (9) any inappropriate status judged by physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of cases with 6qLOH in T-cell lymphoblastic lymphoma and hazard ratio in 3-year event free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| The ratio of cases with positive minimal disseminated disease (MDD) in T or B-cell lymphoblastic lymphoma and each hazard ratio in 3-year event free survival | — |
Countries
Japan
Contacts
Public ContactTakeshi Mori
Kobe University Hospital Department of Pediatrics
Outcome results
None listed