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Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas

ConditionsT-cell Non-Hodgkin LymphomaLymphoma, Extranodal NK-T-Cell
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19-65
SponsorKeimyung University Dongsan Medical Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Age 19 - 65

anaplastic large cell lymphoma

angioimmunoblastic T-cell lymphoma,

peripheral T-cell lymphoma, NOS

Disqualifiers

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.

Patients with a known history of HIV seropositivity or HCV (+).

Trial design

Design model

Single group

Treatments tested in this trial

  • Busulfan

    Drug

    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)

  • Fludarabine

    Drug

    intravenous, 30 mg/m2 + 5% DW 100㎖, over 1 hour once daily for 6 days (days -8 to -3)

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: Experimental ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

2-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

Secondary outcomes

1

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
2

Time to neutrophil engraftment

Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.

Time frame
Day 30
3

Time to platelet engraftment

Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.

Time frame
Day 30
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Keimyung University Dongsan Medical Center

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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