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RecruitingNCT02859402RRTCLAlloSCTUpdated Aug 18, 2022

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

A Phase 2 interventional study of Busulfan and Fludarabine in T-cell Non-Hodgkin Lymphoma and Lymphoma, Extranodal NK-T-Cell, sponsored by Keimyung University Dongsan Medical Center. Recruiting at 2 sites in South Korea. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-18.

Sponsored by Keimyung University Dongsan Medical Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2016; still recruiting 9 years 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

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

Keywords

  • T-cell Non-Hodgkin Lymphoma
  • NK/T-cell Non-Hodgkin Lymphoma
  • Relapsed, refractory
  • Conditioning
  • Allogeneic stem cell transplantation
03

In context

Lymphoma, T-Cell

723 studies on the registry are indexed under Lymphoma, T-Cell; 121 are open to participants now.

This study's planned enrollment of 34 is close to the median of 36 across 628 interventional studies indexed under Lymphoma, T-Cell.

Browse Lymphoma, T-Cell studies →

Lead sponsor

Keimyung University Dongsan Medical Center is the lead sponsor of 86 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Experimental Arm

    Conditioning chemotherapy: Fludarabine and Busulfan followed by Allogeneic stem cell transplantation

    Drug: Busulfan · Drug: Fludarabine

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)

    Also known as: Busulfex

  • DrugFludarabine

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

06

What researchers measure

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

  5. 100-days treatment-related mortality

    Summarized using standard descriptive statistics.

    Time frame: Days 100

  6. Rate of regimen-related toxicities

    Toxicity according to CTCAE version 4.03. Summarized using standard descriptive statistics.

    Time frame: Day 30

  7. Rate of hepatic venoocclusive disease (HVOD)

    Summarized using standard descriptive statistics.

    Time frame: Day 30

  8. Acute graft-versus-host disease (GVHD) grades I-IV

    Summarized using standard descriptive statistics.

    Time frame: Day 100

  9. Chronic GVHD grades I-IV

    Summarized using standard descriptive statistics.

    Time frame: 2 year

  10. Rate of cytomegalovirus (CMV) infection

    Summarized using standard descriptive statistics.

    Time frame: 2 year

07

Study locations

2 of 2 sites recruiting
  • Dong-A University
    Busan, 602-713, South Korea
    Recruiting
  • Keimyung University Dongsan Medical Center
    Daegu, 700-712, South Korea
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — age,gender, disease type, stage, previous chemotherapy regimens, response to transplantation, patient survival, progression, toxicity profiles to the transpantation will be shared

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2016 (actual). Primary completion is estimated for Dec 2025, 108 months after the start.

Of 95 non-industry phase 2 interventional studies under Lymphoma, T-Cell, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 110. This study's planned 108 months is above that.

Counting every sponsor, half of 130 studies reached it within 58 months; a quarter within 33 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2016
First posted
Aug 9, 2016
StartActual
Dec 2016
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2027
Last update
Aug 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02859402
Lead sponsor
Keimyung University Dongsan Medical Center
Collaborators
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Young Rok Do (Prof., Keimyung University Dongsan Medical Center) — Principal investigator
First posted
Aug 9, 2016
Start date
Dec 2016
Primary completion
Dec 2025 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 18, 2022

Study contacts

Young Rok Do, MD., Ph.D.
Contact
dyr1160@dsmc.or.kr
+82-10-3541-1160
Ji Hyun Lee, MD., Ph.D.
Contact
hidrleejh@dau.ac.kr
+82-10-9397-5694

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Busulfan · Fludarabine

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