UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019361 |
|---|---|
| Receipt number | R000022305 |
| Scientific Title | Safety and efficacy of BV-ESHAP therapy for relapsed and refractory Hodgkin's lymphoma before transplantation |
| Date of disclosure of the study information | 2015/10/16 |
| Last modified on | 2016/10/17 11:17:35 |
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Basic information
Public title
Safety and efficacy of BV-ESHAP therapy for relapsed and refractory Hodgkin's lymphoma before transplantation
Acronym
BV-ESHAP for relapsed and refractory Hodgkin's lymphoma
Scientific Title
Safety and efficacy of BV-ESHAP therapy for relapsed and refractory Hodgkin's lymphoma before transplantation
Scientific Title:Acronym
BV-ESHAP for relapsed and refractory Hodgkin's lymphoma
Region
| Japan |
Condition
Condition
Hodgkin's lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examine safety and efficacy of BV-ESHAP therapy for refractory and relapsed Hodgkin's lymphoma before transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall response rate after therapy
(CR and PR on PET-CT)
Key secondary outcomes
collected number of CD34 positive cells/adverse events/Overall survival/relapse-free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
3 to 4 courses of BV therapy(1 course for 21 days)
<BV therapy>
BV 1.8mg/kg day1
Consequently, 1 to 2 courses of ESHAP therapy (1 course for 21 to 28 days)
<ESHAP therapy>
ETP 40mg/m^2 1h div day1,2,3,4
CDDP 25mg/m^2 24hr cont day1,2,3,4
AraC 2g/m^2 2hrs day5
mPSL 500mg/day 30min div day1,2,3,4,5
Administer G-CSF from day7.
Collect peripheral blood stem cells.
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
| 16 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CD30 positive lymphoma cells are confirmed and met all the follows:
Announced that patient is Hodgkin's lymphoma.
Considered that Hodgkin's lymphoma is refractory or relapsed.
Eligible for autologous transplantation.
Performance status is 0 to 3.
Have any calculable lesion radiographically.
AST, ALT is under 2.5 times upper limit of normal controls, and total bilirubin is under 2.0 mg/dl.
Creatinine is under 1.5 mg/dl.
Showed no severe abnormalities on echocardiograms and ultrasonic cardiography.
Showed no interstitial pneumonia.
Have written consents from the patient.
For those under 20 years old, written consents of both the patient and his replacement is required.
Key exclusion criteria
AST, ALT is over 2.5 times upper limit of normal controls, or total bilirubin is over 2.0mg/dl.(exclude for abnormal due to primary disease)
Creatinine is over 1.5 mg/dl.
Showed severe abnormalities on echocardiograms or ultrasonic cardiography, or congestive heart failure.
Have severe interstitial pneumonia, or past history of interstitial pneumonia.
Allergic to etoposide, cytarabine, cisplatin, or G-CSF.
HIV antibody or HBV-DNA is positive.
Have severe uncontrollable disease(for example, cerebral disease, diabetes mellitus, or severe psychological diseases).
Considered as inadequate for this study by study director, or members of this study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Shimizu |
Organization
Keio University
Division name
Department of Hematology
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
taka-sh@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Shimizu |
Organization
Keio University
Division name
Department of Hematology
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
taka-sh@keio.jp
Sponsor or person
Institute
Department of Hematology, Keio University
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology, Keio University
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
| 2015 | Year | 10 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 15 | Day |
Last modified on
| 2016 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022305
| Research Plan | |
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| Registered date | File name |
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