Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

Launched by AB SCIENCE · Jan 28, 2009

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with documented Indolent systemic mastocytosis with handicap (ISMwh) having at least 2 infiltrated\* organs (skin and /or bone-marrow and/or internal organ).
• • 2. Bone-marrow, or skin or internal biopsy-documented mastocytosis and evaluable disease.
• • 3. 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.
• 4. 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 Criteria:
• • 1. Performance status \> 2 (ECOG).
• • 2. Inadequate organ function, except if the abnormalities are due to involvement by mast cells