RecruitingPhase 2NCT02859402

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

Sponsor

Keimyung University Dongsan Medical Center

Enrollment

34 participants

Start Date

Dec 1, 2016

Study Type

INTERVENTIONAL

Conditions

Lymphoma, Extranodal NK-T-Cell T-cell Non-Hodgkin Lymphoma

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

Min Age: 19 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a stem cell transplant using cells donated by another person can effectively treat certain rare and aggressive T-cell or NK-cell lymphomas — blood cancers that have returned or stopped responding to chemotherapy. **You may be eligible if...** - You are between 19 and 65 years old - You have a confirmed diagnosis of a T-cell or NK-cell lymphoma such as anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma, or NK/T-cell lymphoma - Your lymphoma returned or did not respond to at least one previous chemotherapy treatment - Your cancer showed a partial or complete response after rescue chemotherapy - You have a compatible stem cell donor available (a well-matched sibling or unrelated donor) **You may NOT be eligible if...** - Your lymphoma has not responded to any rescue chemotherapy - You do not have a suitable stem cell donor - You have significant organ damage or other serious health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBusulfan

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)

DRUGFludarabine

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

Locations(2)

Dong-A University

Busan, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

View Full Details on ClinicalTrials.gov

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NCT02859402

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