UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001485 |
|---|---|
| Receipt number | R000001803 |
| Scientific Title | Allogeneic stem cell transplantation following reduced-intensity conditioning for relapsed/refractory peripheral T-cell non-Hodgkin's lymphomas |
| Date of disclosure of the study information | 2008/11/07 |
| Last modified on | 2016/05/07 11:45:16 |
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Basic information
Public title
Allogeneic stem cell transplantation following reduced-intensity conditioning for relapsed/refractory peripheral T-cell non-Hodgkin's lymphomas
Acronym
Allogeneic stem cell transplantation following reduced-intensity conditioning for relapsed/refractory peripheral T-cell non-Hodgkin's lymphomas
Scientific Title
Allogeneic stem cell transplantation following reduced-intensity conditioning for relapsed/refractory peripheral T-cell non-Hodgkin's lymphomas
Scientific Title:Acronym
Allogeneic stem cell transplantation following reduced-intensity conditioning for relapsed/refractory peripheral T-cell non-Hodgkin's lymphomas
Region
| Japan |
Condition
Condition
relapsed/refractory peripheral T-cell non-Hodgkin's lymphomas
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of allogeneic stem cell transplantation for relapsed/refractory peripheral T cell lymphoma following reduced intensity conditioning regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival at 1 year after transplantation
Key secondary outcomes
Anti-lymphoma effect at day 100 after transplantation, treatment-related toxicity and mortality at day 100 after transplantation, engraftment at day 60 after transplantation, time to hematopoietic recovery, incidence and severity of acute GVHD
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Reduced-intensity conditioning followed by allogeneic stem cell transplantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PTCL (ALK negative anaplastic large cell lymphoma, Angioimmunoblastic T-cell lymphoma, Peripheral T-cell lymphoma, not other specified)
Patients with diseases described as follows.
SD/PD after first-line chemotherapy or 1st/2nd relapsed patients whose disease is controlled by salvage chemotherapy to CR or PR.
PR/SD after second-line chemotherapy in patients whose response after first-line chemotherapy were PR.
Any of the following is required.
1) Between 16 and 65 years old
2) Performance status(ECOG) 0-2
3) First allogeneic stem cell transplantation
4) Any of the following donors is available.1. Serologically HLA- matched or -one antigen mismatched-related donor 2. HLA-matched or one allele of HLA-DRB1mismatched-unrelated donor
3. Cord blood unit serologically matched at least 4 of 6 HLA antigens(A,B,DR) and with cryopreserved total nucleated cell dose of more than 2x10E7/kg
5) Written informed consent to participate the trial
Key exclusion criteria
Any of the following.
A history of autologous transplantation just before enrolment, Positive for HLA antibody (in case of cord blood transplantation), SaO2 bellow 94% in room air, T.Bil over 2.0 mg/dL, Serum creatinine over 2.0 mg/dL, AST or ALT over 2.5xULN, Uncontrolled diabetes, Uncontrolled hypertension, History of severe cardiac disease, Left ventricular ejection fraction smaller than 50%, Patients with other malignant comorbidity, Uncontrolled active infection, Positive for TPHA or HTLV-1 antibody or HIV antibody or HBs antigen, Uncontrolled psychiatric disease, Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen, Pregnant or during breast feeding, Cases that physicians judged as inappropriate,
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Maeda |
Organization
Okayama University Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
2-5-1 Shikata-cho, Okayama 700-8558
TEL
086-235-7227
yosmaeda@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Maeda, M.D., Ph.D |
Organization
Okayama University Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
2-5-1 Shikata-cho, Okayama 700-8558
TEL
086-235-7227
Homepage URL
yosmaeda@md.okayama-u.ac.jp
Sponsor or person
Institute
West Japan Hematology Oncology Group/ Hematological Malignancy Therapy Study Group/ Japan Study Group for Cell Therapy and Transplantation
Institute
Department
Personal name
Funding Source
Organization
Hematological Malignancy Therapy Study Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2008 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 07 | Day |
Last modified on
| 2016 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001803
