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.
Conditioning therapy * Busulfan (Busulfex®; Patheon Manufacturing Services LLC, Greenville, NC 27834) 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), intravenously for 3 hours once daily for 3 days (days -7 to -5) * Fludarabine (Fludarabine®, Zydus Hospira Oncology Private Ltd., Ahmedabad, India) 30 mg/m2 + 5% DW 100㎖, intravenously for over 1 hour once daily for 6 days (days -8 to -3) * Busulfan should be infused as soon as completion of fludarabine infusion Primary objective of this study I. To determine the 2-year progression-free survival of this reduced toxicity conditioning in relapsed or refractory T- and NK/T-cell non-hodgkin lymphoma patients. Secondary endpoints I. To evaluate the response rate, engraftment rate and time to engraftment, 2-year overall survival, 100-days treatment-related mortality, regimen-related toxicities by CTCAE version 4.03, post-transplantation complications (HVOD, acute/chronic graft-versus-host disease (GVHD), cytomegalovirus (CMV) infection,CMV disease) of this reduced toxicity conditioning in relapsed or refractory T- and NK/T-cell non-hodgkin lymphoma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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)
Dong-A University
Busan, South Korea
RECRUITINGKeimyung University Dongsan Medical Center
Daegu, South Korea
RECRUITING2-year progression-free survival
2 year progression-free survival rate from the date of allogeneic stem cell transplantation. Estimated using the Kaplan-Meier method. Median value will be provided.
Time frame: 2 years
Response rate
Response will be measured after 3 months of the date of allogeneic stem cell transplantation. Mean value will be provided.
Time frame: 3-months
Time to neutrophil engraftment
Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
Time frame: Day 30
Time to platelet engraftment
Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
Time frame: Day 30
2-year overall survival
2 year overall survival rate from the date of allogeneic stem cell transplantation. Estimated using the Kaplan-Meier method. Median value will be provided.
Time frame: 2 years
100-days treatment-related mortality
Summarized using standard descriptive statistics.
Time frame: Days 100
Rate of regimen-related toxicities
Toxicity according to CTCAE version 4.03. Summarized using standard descriptive statistics.
Time frame: Day 30
Rate of hepatic venoocclusive disease (HVOD)
Summarized using standard descriptive statistics.
Time frame: Day 30
Acute graft-versus-host disease (GVHD) grades I-IV
Summarized using standard descriptive statistics.
Time frame: Day 100
Chronic GVHD grades I-IV
Summarized using standard descriptive statistics.
Time frame: 2 year
Rate of cytomegalovirus (CMV) infection
Summarized using standard descriptive statistics.
Time frame: 2 year
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