Phase 2 study of combination chemotherapy(VBL/PSL, MTX, 6MP) 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006016

Enrollment

Registered

2011-08-01

Start date

2011-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult langerhans cell histiocytosis

Interventions

Combination chemotherapy for untreated adult langerhans cell histiocytosis.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Phase 2 overall response rate	—

Countries

Japan

Contacts

Public ContactNaoki Takahashi

International Medical Center, Saitama Medical University Department of Hematology

ntakashi@saitama-med.ac.jp0429844111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026