- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02859402
Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas (RRTCLAlloSCT)
Allogeneic Stem Cell Transplantation With 3-days Busulfan Plus Fludarabine as Conditioning in Patients With Relapsed or Refractory T-, NK/T-cell Lymphomas
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Young Rok Do, MD., Ph.D.
- Phone Number: +82-10-3541-1160
- Email: dyr1160@dsmc.or.kr
Study Contact Backup
- Name: Ji Hyun Lee, MD., Ph.D.
- Phone Number: +82-10-9397-5694
- Email: hidrleejh@dau.ac.kr
Study Locations
-
-
-
Busan, Korea, Republic of, 602-713
- Recruiting
- Dong-A University
-
Contact:
- Ji Hyun Lee, MD., Ph.D.
- Phone Number: +82-10-9397-5694
- Email: hidrleejh@dau.ac.kr
-
Daegu, Korea, Republic of, 700-712
- Recruiting
- Keimyung University Dongsan Medical Center
-
Contact:
- Young Rok Do, MD., Ph.D.
- Phone Number: +82-10-3541-1160
- Email: dyr1160@dsmc.or.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Arm
Conditioning chemotherapy: Fludarabine and Busulfan followed by Allogeneic stem cell transplantation
|
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)
Other Names:
intravenous, 30 mg/m2 + 5% DW 100㎖, over 1 hour once daily for 6 days (days -8 to -3)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: 3-months
|
Response will be measured after 3 months of the date of allogeneic stem cell transplantation.
Mean value will be provided.
|
3-months
|
Time to neutrophil engraftment
Time Frame: Day 30
|
Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
|
Day 30
|
Time to platelet engraftment
Time Frame: Day 30
|
Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
|
Day 30
|
2-year overall survival
Time Frame: 2 years
|
2 year overall survival rate from the date of allogeneic stem cell transplantation.
Estimated using the Kaplan-Meier method.
Median value will be provided.
|
2 years
|
100-days treatment-related mortality
Time Frame: Days 100
|
Summarized using standard descriptive statistics.
|
Days 100
|
Rate of regimen-related toxicities
Time Frame: Day 30
|
Toxicity according to CTCAE version 4.03.
Summarized using standard descriptive statistics.
|
Day 30
|
Rate of hepatic venoocclusive disease (HVOD)
Time Frame: Day 30
|
Summarized using standard descriptive statistics.
|
Day 30
|
Acute graft-versus-host disease (GVHD) grades I-IV
Time Frame: Day 100
|
Summarized using standard descriptive statistics.
|
Day 100
|
Chronic GVHD grades I-IV
Time Frame: 2 year
|
Summarized using standard descriptive statistics.
|
2 year
|
Rate of cytomegalovirus (CMV) infection
Time Frame: 2 year
|
Summarized using standard descriptive statistics.
|
2 year
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
- Lymphoma, Extranodal NK-T-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Fludarabine
- Busulfan
Other Study ID Numbers
- DSMC 2016-05-051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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