Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Q: Who can participate in NCT02859402?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT02859402?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

Allogeneic Stem Cell Transplantation With 3-days Busulfan Plus Fludarabine as Conditioning in Patients With Relapsed or Refractory T-, NK/T-cell Lymphomas

Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas (NCT02859402) is a Phase 2 interventional studying T-cell Non-Hodgkin Lymphoma and Lymphoma, Extranodal NK-T-Cell, sponsored by Keimyung University Dongsan Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against T-cell Non-Hodgkin Lymphoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 34 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 19 - 65 2. diagnosed by tissue sample (biopsy-confirmed) T or NK cell lymphomas : - anaplastic large cell lymphoma - angioimmunoblastic T-cell lymphoma, - peripheral T-cell lymphoma, NOS - NK/T-cell lymphoma 3. Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT. 4. 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 5. Complete or Partial response after short cycles of salvage chemotherapy 6. 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 7. ECOG performance status ≤ 2 8. Charlson Comorbidity Index (CCI) before HSCT ≤ 3 9. Adequate renal function : serum creatinine level \< 2.0 mg/dL 10. 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) 11. Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormality 12. No clinically significant infection 13. No clinically significant bleeding symptoms or sign 14. Patients who decided to participate in this study and signed for a written consent Who Should NOT Join This Trial: 1. Adult T cell leukemia/lymphoma, Lymphoblastic lymphoma, Primary cutaneous CD30+ T cell disorders Mycosis fungoides, Sezary SD 2. Patients who have previously performed Allo-HSCT 3. 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. 4. Patients with a known history of HIV seropositivity or HCV (+). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Age 19 - 65 2. Histologically confirmed T or NK cell lymphomas : * anaplastic large cell lymphoma * angioimmunoblastic T-cell lymphoma, * peripheral T-cell lymphoma, NOS * NK/T-cell lymphoma 3. Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT. 4. 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 5. Complete or Partial response after short cycles of salvage chemotherapy 6. 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 7. ECOG performance status ≤ 2 8. Charlson Comorbidity Index (CCI) before HSCT ≤ 3 9. Adequate renal function : serum creatinine level \< 2.0 mg/dL 10. 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) 11. Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormality 12. No clinically significant infection 13. No clinically significant bleeding symptoms or sign 14. Patients who decided to participate in this study and signed for a written consent Exclusion Criteria: 1. Adult T cell leukemia/lymphoma, Lymphoblastic lymphoma, Primary cutaneous CD30+ T cell disorders Mycosis fungoides, Sezary SD 2. Patients who have previously performed Allo-HSCT 3. 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. 4. 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. 5. Any other malignancies within the past 5 years \*\* Except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri 6. Ejection fraction \< 50% by a echocardiography 7. FEV1 \<60% or DLCO \<60% by a pulmonary function test 8. ECOG performance status 3 or 4 9. 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 10. Pregnant or lactating women, women of childbearing potential not employing adequate contraception

Treatments Being Tested

DRUG

Busulfan

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)

DRUG

Fludarabine

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

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Dong-A University

Busan, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT02859402), the sponsor (Keimyung University Dongsan Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT02859402 clinical trial studying?

Who can participate in NCT02859402?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT02859402?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT02859402. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT02859402. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.