UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000007120