Phase 2 study of combination chemotherapy(VBL/PSL, MTX, 6MP) in patients with primary untreated adult langerhans cell histiocytosis
- Conditions
- adult langerhans cell histiocytosis
- Registration Number
- JPRN-UMIN000006016
- Lead Sponsor
- Department of Hematology, International Medical Center, Saitama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 5
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 2 overall response rate
- Secondary Outcome Measures
Name Time Method