German Treatment Optimization Study for Children with newly diagnosed and relapsed Langerhans cell Histiocytosis (LCH)

Phase 1

• Conditions: angerhans cell Histiocytosis (LCH); Therapeutic area: Not possible to specify

• Registration Number: EUCTR2016-003568-38-DE
• Lead Sponsor: Johann Wolfgang Goethe-University Frankfurt am Main

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-13
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

Stratum I:
•Age: Patients must be less than 18 years of age at the time of enrollment.
•No systemic therapy for LCH prior to the standardized induction therapy, e.g., prior to Initial Course 1 (IC-1) and, eventually, Initial Course 2 (IC-2) (pre-study)
•Evaluation demonstrates non-active disease after IC-1 (independent of involvement of risk organs) or non-active disease or active disease better (only for patients without involvement of risk organs) after IC-2 [imaging studies need to be referenced regarding treatment response to initial course(s) (pre-study)]

Stratum II:
•Age: Patients must be older than 2 years and less than 18 years of age at the time of enrollment
•No systemic therapy for progression/relapse of LCH prior to the standardized second line therapy, e.g., standardized 24-week second-line initial course (SL-IT), which is NOT part of the study
•Evaluation demonstrates non-active disease or active disease better after SL-IT [imaging studies need to be referenced regarding treatment response to second-line initial course (pre-study)].

Both Strata:
•Patients must have a referenced histological verification of the diagnosis of LCH (pre-study)
•Male subjects able to father children and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception (e.g., barrier contraception for males, contraceptive pill (Pill”) for female) throughout the study and for at least 28 days after the last dose of assigned study treatment.
•Signed informed consent form

Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Stratum I:
•Patients with any active disease after IC-1 or patients with active disease intermediate/worse (for patients without involvement of risk organs) or any active disease (for patients with involvement of risk organs) after Initial Course I

Stratum II:
•Patients with progressive disease in risk organs
•Patients with active disease intermediate/worse after second-line intensive course
•Patient suffers from Crohn´s disease or Colitis ulcerosa
•History of asthma, urticaria, or other allergic-type reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs

For both Strata:
•Allergy for one of the trial drugs
•Pregnancy (patients of child-bearing age must be appropriately tested before chemotherapy)
•Breastfeeding
•History of severe bleeding or ulcera of the gastrointestinal tract or other relevant bleeding disorders
•Participation in other clinical trials according to German drug law (§§40ff AMG)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified