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The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients (XOLMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01333293
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : January 18, 2016
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

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 or disease Intervention/treatment Phase
Mastocytosis Drug: injections Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients Prospective Double-blind, Placebo-controlled, Multicentre Study, XOLMA-Study
Study Start Date : September 2011
Actual Primary Completion Date : October 2015
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Experimental: Omalizumab Drug: injections
subcutaneous injections

Placebo Comparator: Placebo Drug: injections
subcutaneous injections

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Effect on the consumption or possibility to reduce mast-cell related drugs [ Time Frame: 10 months ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01333293

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University Hospital Berne (Insel) and Zieglerspital Berne
Berne, Switzerland
Geneva University Hospitals and Medical Faculty of the University of Geneva
Geneva, Switzerland
Allergy Unit, Department of Dermatology, University Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
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Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich

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Responsible Party: University of Zurich Identifier: NCT01333293     History of Changes
Other Study ID Numbers: CIGE025ACH03T V1
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Keywords provided by University of Zurich:
Additional relevant MeSH terms:
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Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Skin Diseases
Immune Complex Diseases
Immune System Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents