UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007927 |
|---|---|
| Receipt number | R000009332 |
| Scientific Title | A feasibility trial of cord blood cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen |
| Date of disclosure of the study information | 2012/05/14 |
| Last modified on | 2018/05/17 22:19:48 |
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Basic information
Public title
A feasibility trial of cord blood cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen
Acronym
A feasibility trial of cord blood cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen (ATL-NST-5)
Scientific Title
A feasibility trial of cord blood cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen
Scientific Title:Acronym
A feasibility trial of cord blood cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen (ATL-NST-5)
Region
| Japan |
Condition
Condition
Adult T cell leukemia/lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety of cord blood cell transplantation for Lymphoma type or acute type of adult T cell leukemia/lymphoma following reduced intensity conditioning regimen.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival after transplantation at day 100 and achievement of engraftment after transplantation before day 100.
Key secondary outcomes
1)Over all survival
2)Disease free survival
3)Anti leukemia/lymphoma effect
4)Anti viral(HTLV-1) effect
5)Incidence and severity of GVHD
6)Other adverse event
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
Cord blood cell transplantation for adult T cell leukemia/lymphoma following reduced intensity conditioning regimen
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Acute or lymphoma type ATL patients.
(2) No suitable related donor, or no suitable unrelated bone marrow donor
(3) Patient must fulfill the following criteria;
1.Age is between 50 and 70 years.
2.A patient ranging age 20 to 49 years is eligible if he (she) fulfills one or more criteria of organ dysfunction described bellow (a) to (d).
(a) Resting ejection fraction between 50 and 60% by UCG.
(b) SaO2 90 to 95% in room air.
(c) Serum Cr level between 1.5 mg/dL and 2.0 mg/dL. (d) T.Bil level between 1.5mg/dL and 2.0 mg/dL or GPT over 3 times of upper limit, under 4 times.
(4)ATL patients whose disease is controlled by the chemotherapy to CR or PR.
(5) ECOG performance status 0 or 1.
(6) Life expectancy beyond 3 months is anticipated by certain treatment.
(7)Written informed consent from the patient.
(8)Present of suitable single unit cord blood
Key exclusion criteria
(1) A patient is uneligible if he (she) has (a) to (d).
(a) Resting ejection fraction bellow 50% by UCG.
(b) SaO2 bellow 90% in room air.
(c) Serum Cr level above 2.0 mg/dL. (d) CCr bellow 20 mL/min/m2.
(e) T.Bil level above 2.0 mg/dL or GPT over 4 times of upper limit.
(2) Uncontrollable active infection.
(3) Active CNS lesion at registration.
(4) Woman who is pregnant, possibly pregnant or breast feeding
(5) On or taking major tranquilizer, antidepressant, antimanic.
(6) History of adverse reaction for the agents included in the protocol in conditioning (fludarabine, melphalan), in GVHD prophylaxis (tacrorimus, MMF, steroids) and G-CSF.
(7) Recipient of previous allogeneic hematopoietic stem cell transplantation.
(8) Positive for HIV antibody.
(9) Positive for HBs antigen.
(10) Have an active cancer.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naokuni Uike |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Division of Hematology
Zip code
Address
3-1-1 Notame Minami-ku Fukuoka-city, Japan
TEL
092-541-3231
nuike@nk-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ilseung Choi |
Organization
National Hospital Organization Kyushu Cancer Center
Division name
Division of Hematology
Zip code
Address
3-1-1 Notame Minami-ku Fukuoka-city, Japan
TEL
092-541-3231
Homepage URL
ilchoi@nk-cc.go.jp
Sponsor or person
Institute
Grant for anticancer project from Ministry of Health, Welfare, and Labor of Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Welfare, and Labor of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
北海道大学血液内科（北海道）
国立がん研究センター中央病院（東京都）
虎の門病院血液科（東京都）
東海大学医学部 血液腫瘍内科（神奈川県）
京都大学血液内科（京都府）
大阪市立大学血液内科（大阪府）
九州大学病院血液腫瘍内科（福岡県）
浜の町病院血液病科（福岡県）
久留米大学血液腫瘍内科（福岡県）
佐賀大学血液内科（佐賀県）
熊本医療センター血液内科（熊本県）
長崎大学原研内科（長崎県）
佐世保市立総合病院血液内科（長崎県）
大分大学病院血液内科（大分県）
大分県立病院血液内科（大分県）
今村病院分院血液内科（鹿児島県）
鹿児島大学病院 血液膠原病内科（鹿児島県）
九州がんセンター血液内科（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 14 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 10 | Day |
Last modified on
| 2018 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009332
