Actively Recruiting
Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas
Led by Keimyung University Dongsan Medical Center · Updated on 2022-08-18
34
Participants Needed
2
Research Sites
573 weeks
Total Duration
On this page
Sponsors
K
Keimyung University Dongsan Medical Center
Lead Sponsor
O
Otsuka Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 19 and 65 years
- Histologically confirmed T-cell or NK/T-cell lymphoma, including anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma NOS, or NK/T-cell lymphoma
- Relapsed or refractory after one or more previous chemotherapy treatments, including frontline autologous HSCT
- At least one measurable lesion on CT or PET CT at relapse or before salvage chemotherapy
- Achieved complete or partial response after short cycles of salvage chemotherapy
- Have an HLA full-match (8/8) or one-locus mismatch (7/8) sibling or unrelated bone marrow, peripheral blood, or cord blood stem cell donor
- ECOG performance status of 2 or less
- Charlson Comorbidity Index (CCI) of 3 or less before HSCT
- Adequate kidney function with serum creatinine below 2.0 mg/dL
- Adequate liver function with AST/ALT less than 3 times upper normal value (or less than 5 times if liver involved) and total bilirubin less than 2 times upper normal value (or less than 5 times if liver involved)
- Cardiac ejection fraction of 50% or higher by MUGA or 2D ECHO without significant abnormalities
- No clinically significant infection
- No clinically significant bleeding symptoms or signs
- Provided written informed consent to participate in the study
You will not qualify if you...
- Diagnosis of adult T cell leukemia/lymphoma, lymphoblastic lymphoma, primary cutaneous CD30+ T cell disorders, mycosis fungoides, or Sezary syndrome
- Previous allogeneic hematopoietic stem cell transplantation (Allo-HSCT)
- T cell lymphoma with primary central nervous system involvement (except patients who had only prophylactic intrathecal or intravenous chemotherapy for CNS disease)
- Known HIV seropositivity or hepatitis C virus (HCV) infection
- Any other malignancy within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Cardiac ejection fraction below 50% by echocardiography
- Pulmonary function with FEV1 below 60% or DLCO below 60%
- ECOG performance status of 3 or 4
- Serious or unstable heart disease despite treatment, recent myocardial infarction within 3 months, serious neurologic or psychiatric disease including dementia or seizure
- Active uncontrolled infections including hepatitis B and C
- Other serious medical problems noted by the treating physicians
- Pregnant or lactating women, or women of childbearing potential not using adequate contraception
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Dong-A University
Busan, South Korea, 602-713
Actively Recruiting
2
Keimyung University Dongsan Medical Center
Daegu, South Korea, 700-712
Actively Recruiting
Research Team
Y
Young Rok Do, MD., Ph.D.
CONTACT
J
Ji Hyun Lee, MD., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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