Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas (RRTCLAlloSCT)
T-cell Non-Hodgkin Lymphoma, Lymphoma, Extranodal NK-T-Cell
About this trial
This is an interventional treatment trial for T-cell Non-Hodgkin Lymphoma focused on measuring T-cell Non-Hodgkin Lymphoma, NK/T-cell Non-Hodgkin Lymphoma, Relapsed, refractory, Conditioning, Allogeneic stem cell transplantation
Eligibility Criteria
Inclusion Criteria:
- Age 19 - 65
Histologically confirmed T or NK cell lymphomas :
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma,
- peripheral T-cell lymphoma, NOS
- NK/T-cell lymphoma
- Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT.
- 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
- Complete or Partial response after short cycles of salvage chemotherapy
- Patients who have HLA full-match (8/8 in HLA-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
- ECOG performance status ≤ 2
- Charlson Comorbidity Index (CCI) before HSCT ≤ 3
- Adequate renal function : serum creatinine level < 2.0 mg/dL
Adequate liver function :
- Transaminase (AST/ALT) < 3 X upper normal value (or < 5 x ULN in the presence of lymphoma involvement of the liver)
- Total bilirubin < 2 X upper normal value (or < 5 x ULN in the presence of NK/T involvement of the liver)
- Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormality
- No clinically significant infection
- No clinically significant bleeding symptoms or sign
- Patients who decided to participate in this study and signed for a written consent
Exclusion Criteria:
- Adult T cell leukemia/lymphoma, Lymphoblastic lymphoma, Primary cutaneous CD30+ T cell disorders Mycosis fungoides, Sezary SD
- Patients who have previously performed Allo-HSCT
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.
Patients with a known history of HIV seropositivity or HCV (+).
** Patients with HBV are eligible. However, primary prophylaxis using antiviral agents is recommended for HBV carrier or prevent HBV reactivation during whole treatment period.
Any other malignancies within the past 5 years
** Except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Ejection fraction < 50% by a echocardiography
- FEV1 <60% or DLCO <60% by a pulmonary function test
- ECOG performance status 3 or 4
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
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Sites / Locations
- Dong-A UniversityRecruiting
- Keimyung University Dongsan Medical CenterRecruiting
Arms of the Study
Arm 1
Experimental
Experimental Arm
Conditioning chemotherapy: Fludarabine and Busulfan followed by Allogeneic stem cell transplantation