Status:
COMPLETED
Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis
Lead Sponsor:
AB Science
Conditions:
Mastocytosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a 12 weeks study aimed at assessing the safety and efficacy of 2 doses of AB1010 in patients suffering from indolent systemic mastocytosis with handicap.
Detailed Description
Efficacy will be assessed based on: Pruritus score Number of flush per day Pollakyuria (on a daily basis) Number of stools per day QLQ-C30 score Hamilton Rating Scale for depression
Eligibility Criteria
Inclusion
- Patients with documented Indolent systemic mastocytosis with handicap (ISMwh) having at least 2 infiltrated\* organs (skin and /or bone-marrow and/or internal organ).
- Bone-marrow, or skin or internal biopsy-documented mastocytosis and evaluable disease.
- The absence of an activating point mutation in the phosphotransferase domain of c-Kit such as D816V c-Kit mutation in at least one of the two infiltrated organs: bone marrow and/or skin and/or other tissue.
- Handicap defined as at least one of the following handicaps:
- a number of flush per day ≥ 1 ,
- a pruritus score ≥ 9 ,
- a number of stools per day ≥ 4 ,
- a Pollakyuria (on a per day basis) ≥ 8 ,
- a QLQ-C30 score ≥ 83 ,
- a Hamilton rating scale for depression ≥ 12
Exclusion
- Performance status \> 2 (ECOG).
- Inadequate organ function, except if the abnormalities are due to involvement by mast cells
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00831974
Start Date
October 1 2004
Last Update
December 11 2018
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