Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas
Allogeneic Stem Cell Transplantation With 3-days Busulfan Plus Fludarabine as Conditioning in Patients With Relapsed or Refractory T-, NK/T-cell Lymphomas
Keimyung University Dongsan Medical Center
34 participants
Dec 1, 2016
INTERVENTIONAL
Conditions
Summary
Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The role of allogeneic stem cell transplantation have been demonstrated in these patients. This clinical trial is studying the efficacy and safety of busulfan plus fludarabine as conditioning therapy followed by allogeneic stem cell transplantation (Allo-SCT) in T- and NK/T-cell lymphoma patients who have relapsed or are refractory to previous chemotherapies including autologous transplantation.
Eligibility
Inclusion Criteria20
- 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 Criteria18
- 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
Interventions
intravenous, 3.2 mg/kg + 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), once daily for 3 hours for 3 days (days -7 to -5)
intravenous, 30 mg/m2 + 5% DW 100㎖, over 1 hour once daily for 6 days (days -8 to -3)
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02859402