Patients with acute myeloid leukemia/acute lymphocytic leukemia/myelodysplastic syndrome/chronic myelomonocytic leukemia categorized as high risk group
Conditions
Interventions
G-CSF combined cytosine arabinoside 2g/square meter x4 +cyclophosphamide 60mg/kg x2 +TBI12Gy will be used as conditioning regimen for AML/MDS/CMMoL patients. For ALL patients, cyclophosphamide 60mg/k
Sponsors
Nagoya Blood and Marrow Transplantation Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (A) AML 1.Pts in CR1 (a)pts with unfavorable or unknown karyotype (b)FAB-M0/M6/M7 (c)pts with intermediate karyotype and non-CR after first-line induction (d)FAB-M3/M3v failed salvage treatment using As2O3, or ATRA, or other synthetic retinoids. 2.CR2 (except pts with t(15;17) in molecular CR) (B)B-ALL 1.High-risk ALL pts in CR1 where high-risk is defined as; (a)pts with evidence of t(9;22) (b)elevated WBC at presentation: >30000/mm3 and >30 years old (c)pts with evidence of 11q23 or MLL gene rearrangement (d)failed to achieve CR after 4 weeks of induction 2. CR2 or later CR (C)T-ALL 1.High-risk T-ALL pts in CR1 where high-risk is defined as; (a)>30 years old (b)elevated WBC at presentation >50000/mm3 2.CR2 (D)MDS Pts categorized as intermediate-2 or high-risk by IPSS score system (E)CMMoL Pts categorized as intermediate-2 or high-risk by CMML scoring system. Pts with MDS and CMMoL in CR1 or chemo-naive are eligible. Pts with MDS and CMMoL treated only with Azacitidine are also eligible. (1)Age between 16 and 55 years (2)(a)Performance states (ECOG)=0 or 1 (b)Hematopoietic stem cell transplantation-specific comorbidity index (HCT-CI)=0 at registration Pts with transient liver dysfunction are eligible. (3)UCB units are available as follows; (a)HLA-A/B/DR serologically match more than 4/6 (b)TNCC of UCB unit is 2.0 x 10E7/kg recipient weight as of frozen (4)First high dose therapy with hematopoietic cell support including auto transplantation (5)Written informed consent to participate the trial
Exclusion criteria
Exclusion criteria: (1)Positive for HIV antibody and/or HBs antigen and/or HCV antibody (2)Graft manipulation such as T-cell depletion (3)history of administration of gemtuzumab ozogamicin within 6 month before transplantation (4)Pregnant or during breast feeding (5)Uncontrolled another neoplastic disease (6)Uncontrolled active psychiatric disease (7)Uncontrolled active infection (8)Allergic history to drugs used in the conditioning regimen or GVHD prophylaxis regimen (9)Patients suggested as ineligible by their attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival rate of patients with successful engraftment at 180 days post-transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to hematopoietic recovery, grade of treatment-associated toxicity by day28, incidence and severity of acute GVHD, incidence and severity of chronic GVHD, treatment-related mortality rate at day180, relapse rate at day180, disease-free survival 2years after transplantation, overall survival 2years after transplantation. | — |
Countries
Japan
Contacts
Public ContactTetsuya Nishida
Nagoya University Graduate School of Medicine Department of Hematology and Oncology
Outcome results
None listed