Acute leukemia, malignant lymphoma, and solid tumor
Conditions
Interventions
Patients receive peripheral blood stem cell transplantation or bone marrow transplantation from HLA-4/8 to 6/8 matched family member after preconditioning with 180mg/m^2 of fludarabine, 140-210mg/m^2
Sponsors
Ibaraki Children's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histologically or cytologically diagnosed acute leukemia, or malignant lymphoma, or solid tumor (2)Age less than 20 years at diagnosis (3)Confirmed Eligible clinical entity (3-1)High Risk acute leukemia or malignant lymphoma (a)Primary induction failure at transplantation (b)In the first complete remission obtained after more than three courses of induction (c)In the first complete remission with detectable minimum residual disease (d)In the first complete remission with unfavorable cytogenetic or molecular features (e)Very early relapse within three years after diagnosis, the second complete remission but poor response or minimum residual disease against re-induction chemotherapy after relapse, the third or more advanced complete remission or not in remission after relapse (3-2)High risk solid tumor (a)MYCN-amplified, 1p-lost, or 11q-lost neuroblastoma (b)Not in remission (3-3)No HLA-match donor in family and no appropriate donor in unrelated donor bank or cord blood bank (3-4)Recurrent acute leukemia or malignant lymphoma after hematopoietic stem cell transplantation (3-5)Recurrent solid tumor (4)ECOG performance status score 0-1, if deterioration due to active disease, score 2 eligible (5)Appropriate organ function fulfilling following condition a)Serum concentration of total bilirubin, less than upper limit of normal range for age b)Serum concentration of creatinine, less than upper limit of normal range for age c)Serum concentration of cystatin C, less than 1.00 mg/L d)Pulse-oximetry saturation more than 97 percent awake and at rest breathing room air e)%Vital capacity, more than 70% by pulmonary function test (if patient more than 6 years old) f)Forced expiratory volume in 1 second%, more than 70% (if patient more than 6 years old) g)Plasma BNP, less than 40 pg/mL h)%Fractional shortening, more than 27% (6)All patients and/or their parents or legal guardians must sign a written informed consent
Exclusion criteria
Exclusion criteria: (1)Germ line chromosomal abnormality other than trisomy 21 (2)Concurrent or prior malignant disease other than the original disease in interest or prior organ transplantation other than hematopoietic cell transplantation (3)Congenital or acquired immunodeficiency (4)Uncontrolled fungal, bacterial, or viral infection (including tuberculosis of HIV) (5)Pregnant, lactating, or highly suspected to be pregnant (6)Corrected QT interval by Fridericia, more than 0.45 second (7)Active hemorrhage in central nervous system, fulfilling grade more than 3 on CTCAE version 4.0 (8)Consciousness disturbance, score less than 14 on Glasgow Coma Scale (9)Obesity, by more than 30% of average weight for age. (10)Considered to be unsuitable for entry for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival rate at day 60 after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Engraftment rate at 30 days after transplantation Achievement rate of complete chimerism at 30 days after transplantation Cumulative incidence of acute GVHD over a 1-year period Cumulative incidence of grade 2 to 4 acute GVHD over a 1-year period Cumulative incidence of grade 3 to 4 acute GVHD over a 1-year period Cumulative incidence of hemorrhagic cystitis over a 1-year period Cumulative incidence of thrombotic microangiopathy over a 1-year period Cumulative incidence of hepatic sinusoidal obstruction syndrome over a 1-year period Cumulative incidence of idiopathic pneumonia syndrome over a 1-year period Cumulative therapy-related mortality over a 2-year period Cumulative incidence of chronic GVHD over a 3-year period Cumulative incidence of severe chronic GVHD over a 3-year period Relapse free survival rate at 1 year after transplantation Overall survival rate at 1 year after transplantation Relapse free survival rate at 3 years after transplantation Overall survival rate at 3 years after transplantation Cumulative incidence of relapse over a 1-year period Cumulative incidence of relapse over a 3-year period | — |
Countries
Japan
Contacts
Public ContactKeisuke Kato, M.D.
Ibaraki Children's Hospital Division of Pediatric Hematology and Oncology, Specialty Care Service, Pediatrics
Outcome results
None listed