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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006016
Receipt No. 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

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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
Email 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
Email ntakashi@saitama-med.ac.jp

Sponsor
Institute Department of Hematology, International Medical Center, Saitama Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007120

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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