Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01266369
Eligibility Criteria:
Inclusion Criteria:
1. Patients with one of the following documented mastocytosis:
* Smouldering systemic mastocytosis
* Indolent systemic mastocytosis with organomegaly
* Indolent Systemic Mastocytosis having 2 infiltrated organs (skin and bone-marrow)
* Any mastocytosis with in the last 6 months at least 3 anaphylactic shocks or syncops requiring either use of adrenaline or medical assistance
* Cutaneous Mastocytosis (CM)
2. Skin biopsy-documented mastocytosis and evaluable disease based upon:
* Histological criteria: typical infiltrates of mast cells in a multifocal or diffuse pattern in skin biopsy
* Clinical criteria: typical skin lesions (maculopapular, urticaria pigmentosa, mastocytoma)
3. Missing data (c-kit molecular analysis not done) or documented presence of an activating point mutation in the phosphotransferase domain of c-kit such as D816V c-kit mutation in at least one infiltrated organ (bone marrow or skin)
4. Refractory to at least one of the symptomatic treatments such as:
* Anti H1
* Anti H2
* Proton pump inhibitor
* Osteoclast inhibitor
* Cromoglycate Sodium
* Antileukotriene
* Other therapies used for the symptomatic care
5. Handicap defined as at least one of the following handicaps:
* pruritus score ≥ 6
* number of flushes per week ≥ 7
* number of stools per day ≥ 4 ,
* number of mictions per day ≥ 8 ,
* QLQ-C30 score ≥ 60,
* Hamilton score ≥ 10
Exclusion Criteria:
1. Patients with one of the following mastocytosis:
* Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD)
* Mast cell leukemia (MCL)
* Aggressive systemic mastocytosis (ASM)
2. Patient with a major surgery within 2 weeks prior to study entry
3. No vulnerable population will be included in this study
* Life expectancy \< 6 months.
* Patient is \< 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ.
* Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
* Patient has a severe and/or uncontrolled medical disease.
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01266369
Study Brief:
Protocol Section:
NCT01266369