T-cell Non-Hodgkin LymphomaPhase 2RRTCLAlloSCTNCT02859402
Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas
A Phase 2 study testing Busulfan and Fludarabine in people with T-cell Non-Hodgkin Lymphoma and Lymphoma, Extranodal NK-T-Cell, run by Keimyung University Dongsan Medical Center at 2 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- T-cell Non-Hodgkin Lymphoma, Lymphoma, Extranodal NK-T-Cell
- What is being tested?
- Busulfan and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2016to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19 - 65
- Histologically confirmed T or NK cell lymphomas :
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma,
- peripheral T-cell lymphoma, NOS
- NK/T-cell lymphoma
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- Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT.
- 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
- Complete or Partial response after short cycles of salvage chemotherapy
- 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
- ECOG performance status ≤ 2
- Charlson Comorbidity Index (CCI) before HSCT ≤ 3
- Adequate renal function : serum creatinine level < 2.0 mg/dL
- 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)
- Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormality
- No clinically significant infection
- No clinically significant bleeding symptoms or sign
- Patients who decided to participate in this study and signed for a written consent
Who cannot join
- 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.
- However, patients who have only had prophylactic intrathecal or intravenous chemotherapy against CNS disease are eligible.
- 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.
Show all 18Show fewer
- Any other malignancies within the past 5 years
- Except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- Ejection fraction < 50% by a echocardiography
- FEV1 <60% or DLCO <60% by a pulmonary function test
- ECOG performance status 3 or 4
- 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
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Dong-A University
Busan, 602-713
Ji Hyun Lee, MD., Ph.D., +82-10-9397-5694, hidrleejh@dau.ac.kr
- Recruiting
Keimyung University Dongsan Medical Center
Daegu, 700-712
Young Rok Do, MD., Ph.D., +82-10-3541-1160, dyr1160@dsmc.or.kr
About this study
Official title: Allogeneic Stem Cell Transplantation With 3-days Busulfan Plus Fludarabine as Conditioning in Patients With Relapsed or Refractory T-, NK/T-cell Lymphomas
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.
- Being tested
- Busulfan, Fludarabine
- Keywords
- T-cell Non-Hodgkin Lymphoma, NK/T-cell Non-Hodgkin Lymphoma, Relapsed, refractory, Conditioning, Allogeneic stem cell transplantation
- Medical subject headings
- Lymphoma, T-Cell, Lymphoma, Extranodal NK-T-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BusulfanDrug
Also called Busulfex
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)
FludarabineDrug
intravenous, 30 mg/m2 + 5% DW 100㎖, over 1 hour once daily for 6 days (days -8 to -3)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Conditioning chemotherapy: Fludarabine and Busulfan followed by Allogeneic stem cell transplantation Receives: Drug: Busulfan; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (10)
Response rate
Response will be measured after 3 months of the date of allogeneic stem cell transplantation. Mean value will be provided.
Measured: 3-months
Time to neutrophil engraftment
Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
Measured: Day 30
Time to platelet engraftment
Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
Measured: Day 30
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.
Measured: 2 years
100-days treatment-related mortality
Summarized using standard descriptive statistics.
Measured: Days 100
Rate of regimen-related toxicities
Toxicity according to CTCAE version 4.03. Summarized using standard descriptive statistics.
Measured: Day 30
Rate of hepatic venoocclusive disease (HVOD)
Summarized using standard descriptive statistics.
Measured: Day 30
Acute graft-versus-host disease (GVHD) grades I-IV
Summarized using standard descriptive statistics.
Measured: Day 100
Chronic GVHD grades I-IV
Summarized using standard descriptive statistics.
Measured: 2 year
Rate of cytomegalovirus (CMV) infection
Summarized using standard descriptive statistics.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Young Rok Do, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859402
- Sponsor's protocol ID
- DSMC 2016-05-051
- Acronym
- RRTCLAlloSCT
- Status last verified
- Aug 2022
- First submitted
- 4 Aug 2016
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: age,gender, disease type, stage, previous chemotherapy regimens, response to transplantation, patient survival, progression, toxicity profiles to the transpantation will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplantation With 3-days Busulfan Plus Fludarabine as Conditioning in Patients With Relapsed or Refractory T-, NK/T-cell Lymphomas
- ClinicalTrials.gov ID
- NCT02859402
- Acronym / sponsor ID
- RRTCLAlloSCT / DSMC 2016-05-051
- Keywords
- T-cell Non-Hodgkin Lymphoma, NK/T-cell Non-Hodgkin Lymphoma, Relapsed, refractory, Conditioning, Allogeneic stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Busulfan, Drug: FludarabineConditioning chemotherapy: Fludarabine and Busulfan followed by Allogeneic stem cell transplantation |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age 19 - 65
- Histologically confirmed T or NK cell lymphomas :
- Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT.
- 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
- Complete or Partial response after short cycles of salvage chemotherapy
Key exclusion criteria (18 listed)
- 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.
- However, patients who have only had prophylactic intrathecal or intravenous chemotherapy against CNS disease are eligible.
- Patients with a known history of HIV seropositivity or HCV (+).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BusulfanAlso: Busulfexintravenous, 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 | Experimental Arm |
| Fludarabineintravenous, 30 mg/m2 + 5% DW 100㎖, over 1 hour once daily for 6 days (days -8 to -3) | Drug | Experimental Arm |
Primary outcome
2-year progression-free survival
Time frame: 2 years
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.
10 secondary outcomes
Response rate
Time frame: 3-months
Time to neutrophil engraftment
Time frame: Day 30
Time to platelet engraftment
Time frame: Day 30
2-year overall survival
Time frame: 2 years
100-days treatment-related mortality
Time frame: Days 100
Rate of regimen-related toxicities
Time frame: Day 30
Rate of hepatic venoocclusive disease (HVOD)
Time frame: Day 30
Acute graft-versus-host disease (GVHD) grades I-IV
Time frame: Day 100
Chronic GVHD grades I-IV
Time frame: 2 year
Rate of cytomegalovirus (CMV) infection
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: Yes. age,gender, disease type, stage, previous chemotherapy regimens, response to transplantation, patient survival, progression, toxicity profiles to the transpantation will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Busulfan and Fludarabine in people with T-cell Non-Hodgkin Lymphoma and Lymphoma, Extranodal NK-T-Cell, run by Keimyung University Dongsan Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young Rok Do, MD., Ph.D. (+82-10-3541-1160, dyr1160@dsmc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.