Thalidomide, Cyclophosphamide and Dexamethasone for Recurrent/Refractory Adult Langerhans Cell Histiocytosis

This is an interventional treatment trial for Langerhans Cell Histiocytosis focused on measuring Langerhans cell histiocytosis, adult, recurrent/refractory Read More

Inclusion Criteria:

• • Histologically confirmed diagnosis of LCH.

  • Patients were recurrent/refractory or at least receive one line of systemic treatment of LCH
  • 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 Criteria:

• • Non-langerhans cell histiocytosis.

  • Patients had concurrent malignancies.
  • Patients who were newly diagnosed 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.