UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Allogeneic stem cell transplantation following reduced-intensity conditioning for relapsed/refractory peripheral T-cell non-Hodgkin's lymphomas
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoshinobu Maeda
Organization	Okayama University Hospital
Division name	Department of Hematology and Oncology
Address	2-5-1 Shikata-cho, Okayama 700-8558
TEL	086-235-7227
Email	yosmaeda@md.okayama-u.ac.jp

Public contact
Name of contact person	Yoshinobu Maeda, M.D., Ph.D
Organization	Okayama University Hospital
Division name	Department of Hematology and Oncology
Address	2-5-1 Shikata-cho, Okayama 700-8558
TEL	086-235-7227
Homepage URL
Email	yosmaeda@md.okayama-u.ac.jp

Sponsor
Institute	West Japan Hematology Oncology Group/ Hematological Malignancy Therapy Study Group/ Japan Study Group for Cell Therapy and Transplantation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2008 Year 09 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001803