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 |
Phase 2 study of combination chemotherapy(VBL/PSL, MTX, 6MP) in patients with primary untreated adult langerhans cell histiocytosis
Combination chemotherapy in patients with primary untreated adult langerhans cell histiocytosis
Phase 2 study of combination chemotherapy(VBL/PSL, MTX, 6MP) in patients with primary untreated adult langerhans cell histiocytosis
Combination chemotherapy in patients with primary untreated adult langerhans cell histiocytosis
Japan |
adult langerhans cell histiocytosis
Hematology and clinical oncology |
Malignancy
NO
In the phase II trial, primary objectives is to evaluate the efficacy and safety of child JLSG maintenance protocol for adult langerhans cell histiocytosis.
Safety,Efficacy
Phase 2
overall response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Combination chemotherapy for untreated adult langerhans cell histiocytosis.
20 | years-old | <= |
70 | years-old | > |
Male and Female
(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.
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.
5
1st name | Naoki |
Middle name | |
Last name | Takahashi |
International Medical Center, Saitama Medical University
Department of Hematology
350-1298
1397 - 1, Yamane, Hidaka, Saitama, Japan
0429844111
ntakashi@saitama-med.ac.jp
1st name | Naoki |
Middle name | |
Last name | Takahashi |
International Medical Center, Saitama Medical University
Department of Hematology
350-1298
1397 - 1, Yamane, Hidaka, Saitama, Japan
0429844111
ntakashi@saitama-med.ac.jp
Department of Hematology, International Medical Center, Saitama Medical University
Department of Hematology, International Medical Center, Saitama Medical University
Other
IRB committee, International Medical Center, Saitama Medical University
1397 - 1, Yamane, Hidaka, Saitama, Japan
0429844523
chikens@saitama-med.ac.jp
NO
2011 | Year | 08 | Month | 01 | Day |
Unpublished
Preinitiation
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 08 | Month | 01 | Day |
2020 | Year | 03 | Month | 31 | Day |
2011 | Year | 07 | Month | 21 | Day |
2020 | Year | 04 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007120