UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006016 |
|---|---|
| Receipt number | R000007120 |
| Scientific Title | Phase 2 study of combination chemotherapy(VBL/PSL, MTX, 6MP) in patients with primary untreated adult langerhans cell histiocytosis |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2020/04/19 17:18:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase 2 study of combination chemotherapy(VBL/PSL, MTX, 6MP) in patients with primary untreated adult langerhans cell histiocytosis
Acronym
Combination chemotherapy in patients with primary untreated adult langerhans cell histiocytosis
Scientific Title
Phase 2 study of combination chemotherapy(VBL/PSL, MTX, 6MP) in patients with primary untreated adult langerhans cell histiocytosis
Scientific Title:Acronym
Combination chemotherapy in patients with primary untreated adult langerhans cell histiocytosis
Region
| Japan |
Condition
Condition
adult langerhans cell histiocytosis
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In the phase II trial, primary objectives is to evaluate the efficacy and safety of child JLSG maintenance protocol for adult langerhans cell histiocytosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase 2
overall response rate
Key secondary outcomes
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
Combination chemotherapy for untreated adult langerhans cell histiocytosis.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(a) Patients with pathologically confirmed langerhans cell histiocytosis(LCH).
(b) Patients had not received prior treatment for LCH. Primary cases.
(c) Patients aged 20-69 years.
(d) PS(ECOG) 0-1
(e) Written informed consent.
Key exclusion criteria
A patient is uneligible if he (she) has (a) to (m).
(a) SaO2 bellow 93% in room air.
(b) Serum Cr level above 2.0 mg/dL.
(c) T.Bil level above 2.0 mg/dL or GPT over 4 times of upper limit.
(d) Uncontrolable DM using insurin.
(e) Uncontrolable Hypertention.
(f) History of myocardial infarction, congestive heart failure, unstable angina.
(g) Resting ejection fraction bellow 50% by UCG.
(h) Have an active cancer.
(i) On or taking major tranquilizer, antidepressant, antimanic.
(j) Uncontrollable active infection.
(k) History of adverse reaction for the agents included in the protocol
(l) Woman who is pregnant, possibly pregnant or breast feeding.
(m) Inadequate for clinical trial entry by the attending physicians.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Takahashi |
Organization
International Medical Center, Saitama Medical University
Division name
Department of Hematology
Zip code
350-1298
Address
1397 - 1, Yamane, Hidaka, Saitama, Japan
TEL
0429844111
ntakashi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Takahashi |
Organization
International Medical Center, Saitama Medical University
Division name
Department of Hematology
Zip code
350-1298
Address
1397 - 1, Yamane, Hidaka, Saitama, Japan
TEL
0429844111
Homepage URL
ntakashi@saitama-med.ac.jp
Sponsor or person
Institute
Department of Hematology, International Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology, International Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB committee, International Medical Center, Saitama Medical University
Address
1397 - 1, Yamane, Hidaka, Saitama, Japan
Tel
0429844523
chikens@saitama-med.ac.jp
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
| 2011 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 21 | Day |
Last modified on
| 2020 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007120
