EUCTR2011-001699-20-GRActive, not recruitingPhase 1
CH-IV International Collaborative Treatment Protocol for Children and Adolescents with LANGERHANS CELL HISTIOCYTOSIS - LCH-IV
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 1,400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients must be less than 18 years of age at the time of diagnosis,
- •Patients must have histological verification of the diagnosis of Langerhans cell histiocytosis according to the criteria described in Section 6.1,
- •Patients with reproductive potential must agree to use effective contraception during the period of therapy,
- •Signed informed consent
- •Stratum II
- •Patients of Stratum I who have progressive disease (AD worse) in non-risk organs after Initial Course 1,
- •AD intermediate or worse in non-risk organs or AD better in risk organs after 12 weeks Initial Course 2,
- •Disease progression (AD worse) in non-risk organs at any time during continuation treatment,
- •Active disease at the end of Stratum I treatment,
- •Disease reactivation in non-risk organs at any time after completion of Stratum I treatment,
- •Disease reactivation in risk-organs, who do not meet organ dysfunction criteria (acc. table XI) at any time or after completion of Stratum I Treatment,
- •Patients with reproductive potential must agree to use effective contraception during the period of therapy
- •Stratum III
- •Patients from Stratum I who fulfill the following criteria:
- •AD intermediate or AD worse in risk organs after week 6 (after Initial Course 1), or AD worse or AD intermediate in risk organs after week 12 (after Initial Course 2),
- •Presence of unequivocally severe organ dysfunction (hematological dysfunction, liver dysfunction, or both of them) as defined in Table XI,
- •Patients with reproductive potential must agree to use effective contraception during the period of therapy
- •Stratum IV
- •Patients from Stratum I or Stratum III who fulfill the following criteria:
- •AD worse in risk organs after week 6 (after Initial Course 1), or AD worse or AD intermediate in risk organs after week 12 (after Initial Course 2) of Stratum I
- •AD worse after the 2nd and 3rd 2-CdA/Ara-C course, and those AD worse or AD intermediate after the 4th 2-CdA/Ara-C course of Stratum III,
- •Presence of unequivocally severe organ dysfunction (hematological dysfunction, liver dysfunction, or both of them) as defined in Table XI (see Section 10.3.1),
- •Signed informed consent,
- •Adequate organ function,
- •Presence of unequivocally severe organ dysfunction (hematological dysfunction, liver dysfunction, or both of them),
- •Patients with reproductive potential must agree to us effective contraception during the period of therapy
- •All patients with verified diagnosis of LCH and MRI findings consistent with ND- CNS-LCH irrespective of previous treatments,
- •Patients with isolated tumorous CNS-LCH (including isolated DI with mass lesion in the hypothalamus-pituitary axis),
- •Patients with reproductive potential must agree to use effective contraception during the period of therapy
- •Stratum VI
- •Patients with newly diagnosed SS-LCH and localization other than multifocal bone”, isolated tumorous CNS lesion, or isolated CNS-risk” lesion
- •Stratum VII
- •All patients registered in LCH IV (regardless of treatment) as long as consent for long- term follow-up has not been withheld
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1400
- •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
- •Pregnancy (patients of child-bearing age must be appropriately tested before chemotherapy),
- •LCH-related permanent consequences (e.g. vertebra plana, sclerosing cholangitis, lung fibrosis, etc.) in the absence of active disease,
- •Prior systemic therapy, except systemic steroids given up to one week
- •Stratum II
- •Patients with progressive disease in risk organs,
- •Permanent consequences (e.g. sclerosing cholangitis, lung fibrosis, etc.) without evidence of active LCH in the same organ or in any other locations,
- •No written consent of the patient or his/her parents or legal guardian
- •Stratum III
- •Isolated sclerosing cholangitis without evidence of active hepatic LCH as the only evidence of risk organ involvement,
- •Inadequate renal function as defined by serum creatinine > 3x normal for age
- •Stratum IV
- •Pulmonary failure (requiring mechanical ventilation) not due to active LCH,
- •Isolated liver sclerosis or pulmonary fibrosis, without active LCH,
- •Uncontrolled active life-threatening infection.
- •Decreased renal function with a GFR of less than 50ml/1.73m2/min,
- •Pregnancy or active breast feeding,
- •Failure to provide signed informed consent
- •Patients without any evidence of isolated tumorous CNS-LCH lesions or ND-CNS lesions
- •Stratum VI
- •Patients with single-system LCH who have an isolated tumorous CNS lesion (eligible for Stratum V),
- •Patients with isolated CNS-risk or multifocal bone lesion (eligible for Stratum I, Group 2)
- •Stratum VII
- •no consent for long-term follow up available
Investigators
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