None listed
Conditions
Interventions
Drug : Conditioning therapy will be started on day -8. Busulfan (Busulfex®
Patheon Manufacturing Services LLC, Greenville, NC 27834) will be given 3.2 mg/kg in 5%
DW (the diluent quantity should be 10 times the volume of Busulfan, so that the final concentration of busulfan becomes approximately 0.5 mg/mL) and will be given intravenously once daily for 3 hours
DW 100? and will be infused for over 1 hour once daily for 6 days (days -8 to -3). Busulfan should be infused as soon as completion of fludarabine infusion.
Sponsors
Keimyung University Dongsan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 19 - 65 2. Histologically confirmed T or NK(Natural Killer) cell lymphomas : - anaplastic large cell lymphoma - angioimmunoblastic T-cell lymphoma, - peripheral T-cell lymphoma, NOS(Not Otherwise Specified) - extradonal NK(Natural Killer)/T-cell lymphoma, nasal type 3. Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT(Hematopoietic Stem Cell Transplant). 4. At least one measured lesion using conventional CT or PET CT at the time of relapse after or refractory to one or more of previous chemotherapy and before salvage chemotherapy 5. Complete or Partial response after short cycles of salvage chemotherapy 6. Patients who have HLA(human leukocyte antigen) full-match (8/8 in HLA(human leukocyte antigen)-A, B, C, DR by DNA high-resolution technique) or one-locus mismatch (7/8) sibling, or unrelated bone marrow or peripheral blood or cord blood stem cell donors 7. ECOG(Eastern Cooperative Oncology Group ) performance status = 2 8. Charlson Comorbidity Index (CCI) before HSCT(Hematopoietic Stem Cell Transplant) = 3 9. Adequate renal function : serum creatinine level < 2.0 mg/dL 10. Adequate liver function : – Transaminase (AST(aspartate aminotransferase)/ALT(alanine aminotransaminase)) < 3 X upper normal value (or < 5 x upper normal value in the presence of lymphoma involvement of the liver) – Total bilirubin < 2 X upper normal value (or < 5 x upper normal value in the presence of NK(Natural Killer)/T involvement of the liver) 11. Cardiac ejection fraction = 50 % as measured by MUGA(multigated acquisition) or 2D ECHO(echocardiography) without clinically significant abnormality 12. No clinically significant infection 13. No clinically significant bleeding symptoms or sign 14. Patients who decided to participate in this study and signed for a written consent
Exclusion criteria
Exclusion criteria: 1. Adult T cell leukemia/lymphoma, Lymphoblastic lymphoma, Primary cutaneous CD30+ T cell disorders Mycosis fungoides, Sezary Syndrome 2. Patients who have previously performed Allo-HSCT(Hematopoietic Stem Cell Transplant) 3. T cell lymphoma with primary central nervous system (CNS) Involvement. ** However, patients who have only had prophylactic intrathecal or intravenous chemotherapy against CNS disease are eligible. 4. Patients with a known history of HIV(human immunodeficiency virus) seropositivity or HCV(hepatitis C virus) (+). ** Patients with HBV are eligible. However, primary prophylaxis using antiviral agents is recommended for HBV carrier or prevent HBV(hepatitis B virus) reactivation during whole treatment period. 5. Any other malignancies within the past 5 years ** Except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 6. Ejection fraction < 50% by a echocardiography 7. FEV1(Forced Expiratory Volume in One Second) <60% or DLCO(Pulmonary diffusion capacity of carbon monoxide) <60% by a pulmonary function test 8. ECOG(Eastern Cooperative Oncology Group ) performance status 3 or 4 9. Combined serious medical problem or disease - Serious or unstable heart disease although proper treatment - Myocardial infarction in recent 3 months - Underlying serious neurologic or psychiatric disease including dementia or seizure - Active uncontrolled infection including hepatitis B and C - Serious other medical problems observed by the doctors in charge of the patient 10. Pregnant or lactating women, women or men of childbearing potential not employing adequate contraception 11. History of hypersensitivity, allergy or intolerance to the study drug 12. History of fatal hemolytic anemia due to the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate of the T-, NK/T-cell lymphoma;Engraftment rate and time to engraftment;2-year overall survival;100-days treatment-related mortality;Regimen-related toxicities by CTCAE(Common Terminology Criteria for Adverse Events) version 4.03;Post-transplantation complications (HVOD, acute/chronic graft-versus-host disease (GVHD), cytomegalovirus (CMV) infection,CMV disease) | — |
Countries
Korea, Republic of
Contacts
Public ContactJi Hyun Lee
Dong-A University Hospital
Outcome results
None listed