Hematologic malignancy
Conditions
Interventions
(1) Fludarabine, 30 mg/m2/day, div, on days -8 to -3 (2) Busulfan, 3.2 mg/kg/day div, divided into 4 doses, on days -6 and -5 (3) Anti-T-lymphocyte immunoglobulin (ATG-Fresenius), 5 mg/kg/day div,
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Hematologic malignancy (a) Acute myeloid leukemia High risk CR1 CR2 or later CR Relapse or primary refractory* *who do not require chemotherapy for 1 month (b) Myelodysplastic syndrome IPSS intermediate-2 or high Require blood transfusion of 10 units/week platelet or 2 units/week red blood cell *Patients who have not received standard chemotherapy are ineligible. (c) Chronic myeloid leukemia CP2 or later CP CP1 with gleevec failure *Patients who have not received standard chemotherapy are ineligible. (d) Malignant lymphoma 1. Indolent lymphoma including chronic lymphocytic leukemia *First or later relapse/progression. 2. Aggressive lymphoma or Hodgkin lymphoma *First or later relapse/progression with sensitivity to prior chemotherapy. (2) No available HLA 6/6 matched or 5/6 matched related donor. (3) Available HLA 8/8, 7/8, or 6/8 allele-matched unrelated donor (4) Age at transplantation: between 16 years and 65 years (5) ECOG performance status: 0 or 1 (6) Ineligible for myeloablative conditioning due to (A) older age (50 years or older), (B) organ dysfunction as mentioned below, or (C) a history of high-dose chemotherapy or total-body irradiation followed by autologous hematopoietic stem cell transplantation within 6 months. (a) EF 40%-50% (b) %VC 30%-40%, FEV1.0% 40%-50%, or PaO2 60-80 mmHg or SO2 90-95% on room air (c) Serum Cr 1.5-2.0 mg/dl or above (d) Serum bilirubin 1.5-2.0 mg/dl or ALT(GPT) 2-3xUNL (7) Obtained informed consent from patients (8) Expected to live at least 3 months after transplantation
Exclusion criteria
Exclusion criteria: (1) Patients with organ dysfunction as defined below are excluded. (a) EF <40% (b) %VC <30%, FEV1.0% <40%, or PaO2 <50 mmHg or SO2 <90% on room air (c) Serum Cr 2.0 mg/dl or above (d) Serum bilirubin >2.0 mg/dl, ALT(GPT) >3xUNL, chronic active hepatitis, or liver cirrhosis. (2) Uncontrollable hypertension (3) Positive anti-HIV antibody (4) Uncontrollable active infection (5) Uncontrollable CNS disease (6) During pregnancy or breast-feeding (7) Patients with severe psychiatric problems (8) Allergy to drugs for conditioning and GVHD prophylaxis (9) Patients who are considered as ineligible by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Day 100 survival with donor cell engraftment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year OS and PFS 1-year non-relapse mortality Primary and secondary graft failure Time to neutrophil engraftment and complete chimerism Acute and chronic GVHD Regimen-related toxicity (CTCAE ver 3.0) Relapse or progression Bacterial, fungal, and viral infection Immune reconstitution | — |
Countries
Japan
Contacts
Public ContactFukuda, Takahiro
National Cancer Center Hospital Hematopoietic Stem Cell Transplantation Division
Outcome results
None listed