CompletedPhase 2

Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis

23 participantsStarted 2004-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:

Exclusion criteria

✕. Performance status \> 2 (ECOG).
✕. Inadequate organ function, except if the abnormalities are due to involvement by mast cells

What they're measuring

Response 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

Timeframe: 12 weeks

Trial details

NCT IDNCT00831974

SponsorAB Science

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-02

View on ClinicalTrials.gov More Mastocytosis trials