Hematological malignancy
Conditions
Interventions
Cy is intravenously administered at 50mg/kg/day on days 3 and 4. Continuous intravenous infusion of Tac is started at 0.03mg/kg/day from day 5. Unless GVHD developed, Tac was tapered from day 60-100 a
Sponsors
Nakamae Hirohisa
Hino Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Disease (a) AML (b) ALL (c) Acute leukemias of ambiguous lineage (d) MDS 1. IPSS int-2 or high, or IPSS-R intermediate, poor or very poor 2. Transfusion dependent MDS (more than 2 unit RBC or 10 unit platelet weekly transfusion) (e) CML 1. CP beyond 1st CP 2. TKI failure in 1st CP (f) malignant lymphoma 1. Indolent lymphoma after 1st relapse/progression 2. Aggressive lymphoma *Chemo-refractory lymphoma after 1st relapse, or *Lymphoma after 2nd relapse, or *relapsed Lymphoma after auto-HCT (g) Other, hematological malignancy that was judged as necessity of allo-HCT in our conference (2) Age >=15 and < 70 years old (3) ECOG PS 0 or 1 (4) Normal function of major organs (5) donor: presence of available sibling or unrelated donor with HLA-A, B, C, and DRB1 allele 8/8 match in GVH direction (Note: no limitation for conditioning regimen intensity)
Exclusion criteria
Exclusion criteria: 1) Major organ dysfunction a) Total bilirubin:>= 2.0mg/dl b) Serum creatinine: >= 2.0mg/dl c) Ejection fraction: = 3 x UNL 2) Uncontrolled active infection 3) Uncontrolled CNS invasion 4) Poorly controlled insulin-treated diabetes mellitus 5) Poorly controlled hypertension 6) Patients with a severe complication including heart failure, liver failure, acute myocardial infarction within the last three months, liver cirrhosis and interstitial pneumonia 7) Pregnant, lactating or possible fertile women who may become pregnant 8) Patients with a severe mental who are likely to be unable to participate in the study 9) A history of hypersensitivity or allergy to any drugs in the conditioning regimen of this transplant 10) HIV antibody positivity 11) The administration of ATG is scheduled in conditioning regimen. 12) The physician in charge determines that there is no indication to perform this intervention. (Note: HBs antigen positivity and HCV antibody positivity is not exclusion criterion.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year chronic GVHD cumulative incidence | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall survival, relapse rate 2) Non-relapse mortality 3) GVHD and relapse-free survival: GRFS 4) Incidence of primary and secondary engraftment failure 5) Time to hematopoietic recovery, time to complete donor chimerism 6) Incidence and severity of acute and chronic GVHD 7) Regimen related toxicity 8) Incidence of bacterial, fungal and viral infections 9) Immune reconstruction | — |
Contacts
Public ContactHirohisa Nakamae
Osaka City University Graduate School of Medicine
Outcome results
None listed