The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients (XOLMA)
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Purpose
Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo, fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast media, local anesthetics or analgesics. In addition, there is increased osteoporosis in mastocytosis patients due to the activity of mast cell mediators on osteoblasts and osteoclasts. Symptoms of mastocytosis respond poorly to treatment with antihistamines or other antiallergic drugs. There is currently no specific treatment for this disease with the exception of rare cases. There are, however, some case reports suggesting that omalizumab might decrease symptoms including hypotensive events.
The aim of the study is to investigate whether patients suffering from mastocytosis benefit from a 6 month course of omalizumab with regard to symptoms and quality of life and whether the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the efficacy of omalizumab in patients with mastocytosis.
- Trial with medicinal product
| Condition | Intervention | Phase |
|---|---|---|
|
Mastocytosis |
Drug: injections |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients Prospective Double-blind, Placebo-controlled, Multicentre Study, XOLMA-Study |
- Reduction of mast-cell induced adverse events and symptoms as summarized and calculated from patient's main complaint score and AFIRM score. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
- Effect on the consumption or possibility to reduce mast-cell related drugs [ Time Frame: 10 months ] [ Designated as safety issue: No ]
- Effect on: - Lung function (FEV1), analysed by standard lung function measurements - blood pressure, - quantitative measurement of pressure-induced wheal and flare. [ Time Frame: 10 months ] [ Designated as safety issue: No ]
- Effect on in-vitro parameters (Tryptase levels, density of Fc-IgE-R expression on basophils, Platelet-Activation-Factor (PAF) and cysteinyl leukotriene LTC4) [ Time Frame: 10 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Omalizumab |
Drug: injections
subcutaneous injections
|
| Placebo Comparator: Placebo |
Drug: injections
subcutaneous injections
|
Detailed Description:
The study will take place as double-blind placebo controlled study. After a first a run-period of 2 months for all participants randomization (1:1) in two group will take place:
Group A: With omalizumab treatment for 6 months; dosage and administration schedule according to body weight and total IgE level (1/2 of the patients). Group B: Placebo (1/2 of the patients). After 4 months of treatment in both groups patients are encouraged to stop all drugs given to reduce mast cell related effects, mainly antihistaminics . In case that disturbing symptoms are reoccurring patients are allowed to restart these drugs. The evaluation will take place after 5 months of treatment.
Finally, a follow up visit 1 and 4 months after the study will take place.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Histological proven mastocytosis (cutaneous or systemic);
- Diagnosis made by one marrow unction and/or skin biopsy or other histological work up;
- Age: 18-70 years
Exclusion criteria
- Age <18 years;
- Known hypersensitivity to omalizumab or any of its components;
- History of cancer in previous 5 years;
- Patients with serious infections;
- Patients with active tuberculosis or undergoing anti-TB therapy;
- Patients currently treated with systemic immunosuppressive agents;
- Female patients who are pregnant or breast feeding;Contraception must be performed by a save reliable and accept method such as oral or implanted contraceptives, intravaginal or male preservatives or permanent methods such as tubal ligation.
- Patients with known positivity for human immunodeficiency virus (HIV). HIV screening will be performed by an HIV 1/2 Antibody-detection test.
Note: Specific immunotherapy for insect sting allergy is no exclusion criteria.
Contacts and Locations| Contact: 01 Studienregister MasterAdmins | +41 (0)44 255 11 11 |
| Switzerland | |
| University Hospital Berne (Insel) and Zieglerspital Berne | Not yet recruiting |
| Berne, Switzerland | |
| Contact: Arthur Helbling, MD Arthur.helbling@insel.ch | |
| Geneva University Hospitals and Medical Faculty of the University of Geneva | Not yet recruiting |
| Geneva, Switzerland | |
| Contact: Jörg Seebach, MD joerg.seebach@hcuge.ch | |
| Allergy Unit, Department of Dermatology, University Hospital Zurich | Recruiting |
| Zurich, Switzerland | |
| Contact: Peter Schmid-Grendelmeier, MD +41442551111 peter.schmid@usz.ch | |
| Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
More Information
No publications provided
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01333293 History of Changes |
| Other Study ID Numbers: | CIGE025ACH03T V1 |
| Study First Received: | July 20, 2009 |
| Last Updated: | October 19, 2011 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University of Zurich:
|
mastocytosis omalizumab |
Additional relevant MeSH terms:
|
Mastocytosis Urticaria Pigmentosa Mastocytoma Mastocytosis, Cutaneous Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Skin Diseases Pigmentation Disorders Omalizumab Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 19, 2013