Status:
UNKNOWN
AraC for Newly Diagnosed Adult Langerhans Cell Histiocytosis
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Langerhans Cell Histiocytosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Langerhans cell histiocytosis (LCH) is a rare, heterogeneous histiocytic disorder occurring in patients of all ages from neonates to the elderly. The current standard treatment protocol for children w...
Eligibility Criteria
Inclusion
- • Histologically confirmed diagnosis of LCH.
- Patients were newly diagnosed or did not receive prior systemic treatment of LCH (patients who had received radiotherapy alone were allowed).
- Age ≥18 years and ≤75 years.
- LCH involved multisystem or multifocal single system.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patients must have adequate renal, liver, and bone marrow function as defined by the following criteria:
- Absolute neutrophil count ≥1500 cells per mm3 or ≥500 cells per mm3 in the case of known hematopoietic system involvement by LCH.
- Platelet count ≥100000 cells per mm3 or ≥20000 cells per mm3 in the case of known hematopoietic system involvement by LCH.
- Creatinine clearance \[according to Cockcroft formula\] ≥60 mL/min.
- Aspartate aminotransferase and alanine aminotransferase ≤2·5×upper limit of normal \[ULN\], and total bilirubin ≤2·5×ULN; or ≤10×ULN in the case of known liver involvement by LCH.
- No active or untreated infection.
- No cardiac abnormalities.
- Subject provide written informed consent.
- A female is eligible to enter and participate in this study if she is of:
- Non-childbearing potential including ω Any female who has had a surgical procedure rendering her incapable of becoming pregnant.
- ω Subjects have experienced total cessation of menses for more than 1 year and be greater than 45 years in age.
- ⎫ Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, and agrees to use adequate contraception.
- Male subjects must use an effective barrier method of contraception during the study and for 90 days following the last course of MA if sexually active with a childbearing potential
Exclusion
- • Non-langerhans cell histiocytosis.
- Patients had concurrent malignancies.
- Patients who had received any treatment except radiotherapy for LCH.
- History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
- Women who were pregnant or of childbearing potential.
- Known HIV seropositive, active hepatitis C infection, and/or hepatitis B (defined as HCV RNA
- ≥103 copies or HBV DNA ≥103 copies at screening).
- Major surgical procedure within 28 days prior to the first dose of study treatment.
- Presence of uncontrolled infection.
- Evidence of active bleeding or bleeding diathesis.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04121819
Start Date
October 1 2019
End Date
December 31 2021
Last Update
June 8 2021
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China