Phase 2
Completed N=5
Study of Sequential Administration of Oral 6-Thioguanine After Methotrexate in Patients With LCH
Source: ClinicalTrials.gov NCT00588536 ↗Enrolled (actual)
5
Serious AEs
40.0%
Results posted
May 2015
Primary outcomePrimary: Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX. — 2; 1; 2 participants
Summary
The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with Langerhans Cell Histiocytosis (LCH) treated with sequential administration of oral 6-Thioguanine (6-TG) after Methotrexate (MTX).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Incidence of Complete and Partial Response and the Duration of Response in Patients With Langerhans Cell Histiocytosis (LCH) Treated With Sequential Administration of Oral 6-TG After MTX. |
2; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with histologic proof of LCH who have multifocal or multisystem disease involvement.
- Patients must have a life expectancy of at least 8 weeks.
- All patients must have ECOG performance level rating of- \_ 60 ml/min/1.73 m2) and normal electrolytes.
- Patients should have a granulocyte count > 500/uL and a platelet count >\_ 100,000/uL (unless due to disease involvement of the bone marrow).
- Male and female patients of child-bearing age should use effective methods of contraception, if sexually active.
Exclusion Criteria
- Patients with active infections or significant medical conditions other than their disease (LCH) shall be excluded.
Data sourced from ClinicalTrials.gov (NCT00588536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.