| 1 |
NCT02620254 |
Recruiting |
Mast Cell Connect: A Registry for Patients With Mastocytosis |
|
|
Observational |
|
- Blueprint Medicines Corporation
- PatientCrossroads
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Further the understanding of the epidemiology of mastocytosis and its subtypes
|
200 |
All |
Child, Adult, Senior |
NCT02620254 |
Mastocytosis Registry |
|
November 2015 |
December 2020 |
December 2020 |
December 2, 2015 |
September 20, 2017 |
|
- Registry participation is worldwide and not limited to this facility
Cambridge, Massachusetts, United States
|
| 2 |
NCT01333293 |
Completed |
The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients |
|
|
Interventional |
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Reduction of mast-cell induced adverse events and symptoms as summarized and calculated from patient's main complaint score and AFIRM score.
- Effect on the consumption or possibility to reduce mast-cell related drugs
- Effect on: - Lung function (FEV1), analysed by standard lung function measurements - blood pressure, - quantitative measurement of pressure-induced wheal and flare.
- Effect on in-vitro parameters (Tryptase levels, density of Fc-IgE-R expression on basophils, Platelet-Activation-Factor (PAF) and cysteinyl leukotriene LTC4)
|
17 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01333293 |
CIGE025ACH03T V1 |
XOLMA |
September 2011 |
October 2015 |
January 2016 |
April 11, 2011 |
January 18, 2016 |
|
- 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
|
| 3 |
NCT02441166 |
Recruiting |
Diagnostic Value of Bone Marrow Tryptase in Systemic Mastocytosis |
|
- Procedure: Mastocytosis diagnosis
|
Interventional |
Not Applicable |
- University Hospital, Toulouse
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Bone marrow tryptase level
- The bone marrow tryptase level for differential diagnosis between systemic mastocytosis and cell mast activation syndrome
- The bone marrow tryptase/serum tryptase ratio for diagnosis of systemic mastocytosis with and without mastocytosis in skin
- (and 3 more...)
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT02441166 |
RC31/14/7387
2015-A00351-48 |
EvaTryMS |
October 6, 2015 |
December 2019 |
December 2020 |
May 12, 2015 |
January 29, 2018 |
|
- CHU Bordeaux Hôpital Haut-Lévêque, service de dermatologie
Bordeaux, France - CHU de Caen, service d'hématologie
Caen, France - CHU Dupuytren service d'hématologie
Limoges, France - (and 5 more...)
|
| 4 |
NCT01701843 |
Terminated |
Cromoglicate in Mastocytosis |
|
- Drug: Cromoglicate
- Drug: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Evaluation of mechanically induced changes of lesions
- Evaluation of mechanically induced wheal and flare response
|
7 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01701843 |
LP0074-33 |
|
October 2012 |
February 2013 |
February 2013 |
October 5, 2012 |
March 7, 2013 |
|
- Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin
Berlin, Germany
|
| 5 |
NCT01602939 |
Recruiting |
Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis |
|
- Drug: Cladribine and pegylated interpheron alpha-2a
|
Interventional |
Phase 2
Phase 3 |
- Hospital Virgen de la Salud
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the effect of therapy on bone marrow mast cell infiltration.
- To determine the effect of therapy on serum tryptase levels and other altered peripheral blood parameters due to mastocytosis.
- To evaluate the effect of therapy on mast cell-mediator release symptoms: pruritus, flushing, gastrointestinal symptoms or anaphylaxis).
- (and 4 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT01602939 |
EC11-187 |
|
May 2012 |
February 2017 |
June 2017 |
May 21, 2012 |
August 29, 2016 |
|
- Instituto de Estudios de Mastocitosis de Castilla La Mancha; Hospital Virgen del Valle
Toledo, Spain
|
| 6 |
NCT01297777 |
Completed |
Imatinib in KIT-negative Systemic Mastocytosis |
|
|
Interventional |
Phase 4 |
- Hospital Virgen de la Salud
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the effect of Imatinib Mesylate on the grade of bone marrow mast cells infiltration.
- To evaluate the effect of Imatinib Mesylate on mastocytosis skin lesions.
- To evaluate the effect of Imatinib Mesylate on mastocytosis mast-cell related symptoms.
- (and 5 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT01297777 |
EudraCT 2010-019189-94 |
|
January 2011 |
August 2015 |
August 2015 |
February 17, 2011 |
August 29, 2016 |
|
- Instituto de Estudios de Mastocitosis de Castilla La Mancha; Hospital Virgen del Valle
Toledo, Spain
|
| 7 |
NCT01481909 |
Completed |
Study on Mastocytosis for Rupatadine Treatment |
|
|
Interventional |
Phase 2
Phase 3 |
- Marcus Maurer
- Charite University, Berlin, Germany
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
30 |
All |
18 Years to 65 Years (Adult) |
NCT01481909 |
SMART-2010-1 |
SMART |
September 2010 |
August 2011 |
November 2011 |
November 30, 2011 |
November 3, 2016 |
|
- University Charité
Berlin, Germany
|
| 8 |
NCT01920204 |
Unknown † |
Midostaurin in Indolent Systemic Mastocytosis |
- Indolent Systemic Mastocytosis
|
|
Interventional |
Phase 2 |
- University Medical Center Groningen
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Symptom Scoring
- Persistence of improvements
- Mast cell burden
- Adverse events
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT01920204 |
UMCG41973 |
|
August 2013 |
March 2015 |
May 2015 |
August 9, 2013 |
January 19, 2015 |
|
- University Medical Center Groningen
Groningen, Netherlands
|
| 9 |
NCT00831974 |
Completed |
Efficacy of AB1010 in Patients With Systemic Indolent Mastocytosis |
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 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
- AFIRMM score, reduction of organ infiltration,level of tryptase, reduction on bio markers (TNFα, eosinophils, histamine levels), pharmacokinetic profile of AB1010
|
23 |
All |
18 Years and older (Adult, Senior) |
NCT00831974 |
AB04010 |
|
October 2004 |
February 2007 |
|
January 29, 2009 |
August 14, 2013 |
|
|
| 10 |
NCT00449748 |
Completed
Has Results |
Everolimus (RAD001) as Therapy for Patients With Systemic Mastocytosis |
|
- Drug: RAD001 (Everolimus)
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
- Novartis Pharmaceuticals
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Objective Response
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT00449748 |
2006-0759 |
|
April 2007 |
October 2009 |
October 2009 |
March 21, 2007 |
August 7, 2012 |
April 29, 2011 |
- The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
|
| 11 |
NCT01334996 |
Unknown † |
Use of Tamoxifen in Systemic Mastocytosis |
|
|
Observational |
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Stability or reduction of the percent bone marrow involvement by mastocytosis, including stable mast cell morphology and phenotype.
- Stability or improvement in biochemical markers of systemic mastocytosis
|
6 |
All |
21 Years and older (Adult, Senior) |
NCT01334996 |
2506-04 |
|
February 2005 |
December 2014 |
December 2014 |
April 13, 2011 |
August 12, 2014 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
| 12 |
NCT02478957 |
Completed |
Treatment of Indolent Systemic Mastocytosis With PA101 |
- Mastocytosis
- Systemic Mastocytosis
- Indolent Systemic Mastocytosis
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Overall symptom score
- Disease specific quality of life (QoL)
- Patient Global Impression of Change (PGIC) scale
|
41 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02478957 |
PA101-SM-02 |
|
June 2015 |
March 2016 |
June 2016 |
June 23, 2015 |
September 29, 2016 |
|
- Hopital Necker - Enfants Malades
Paris, France - Charité - Universitätsmedizin Berlin
Berlin, Germany - Klinikum Darmstadt
Darmstadt, Germany - (and 5 more...)
|
| 13 |
NCT00457288 |
Completed |
Efficacy and Safety of TF002 in Cutaneous Mastocytosis |
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Clinical evaluation of treatment response
- Number of skin mast cells
- Volumetric and thermographic analyses
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT00457288 |
MICUMA |
|
April 2007 |
|
September 2007 |
April 6, 2007 |
November 12, 2007 |
|
- Klinik und Poliklinik für Dermatologie und Venerologie der Universität
Köln, Germany - Universitäts-Hautklinik
Mainz, Germany - Klinik und Poliklinik für Dermatologie und Allergologie der LMU
München, Germany - Klinik und Poliklinik für Dermatologie und Allergologie am Biederstein der TU
München, Germany
|
| 14 |
NCT00050193 |
Completed |
Cause and Natural Course of Pediatric-Onset Mastocytosis |
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
103 |
All |
up to 21 Years (Child, Adult) |
NCT00050193 |
030041
03-I-0041 |
|
November 22, 2002 |
|
March 10, 2014 |
November 26, 2002 |
April 17, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 15 |
NCT00336076 |
Completed |
Molecular Mechanisms and Diagnosis of Mastocytosis |
|
- Other: Collection of blood and bone marrow
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Proportion of the patients with clonal and non-clonal mast cell disorders
- Proportion of KIT D816V mutation in blood, bone marrow and sorted mast cells
|
136 |
All |
Child, Adult, Senior |
NCT00336076 |
2004-0246 |
|
July 2004 |
December 2008 |
July 2009 |
June 12, 2006 |
November 7, 2016 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
| 16 |
NCT00979160 |
Unknown † |
Evaluation of Response of Dasatinib to Treat Mastocytosis |
|
|
Interventional |
Phase 2 |
- Federico II University
- University of Bologna
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To assess the clinical response rate in terms of both B/C findings and mediator-related symptoms in subjects with SM who have been treated with dasatinib.
- To assess of the Time to Response (TTR), Duration of Response (DOR) and Progression-Free survival (PFS).
- To evaluate the changes in specific biological markers and molecular mutations.
- To evaluate the safety and toxicity of dasatinib in this population.
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT00979160 |
CA 180-287 |
|
November 2009 |
December 2011 |
December 2012 |
September 17, 2009 |
September 18, 2009 |
|
- Istituto di ematologia "L e A Seragnoli" - Policlinico universitario Sant'Orsola-Malpighi
Bologna, Italy - Dipartimento di Ematologia - S.O.D. di Ematologia Università degli Studi di Firenze - Azienda Ospedaliera Careggi
Firenze, Italy - Divisione di Ematologia Ospedale Niguarda Ca' Grande
Milano, Italy - (and 9 more...)
|
| 17 |
NCT01266369 |
Completed |
Masitinib in Patients With Mastocytosis With Handicap and Bearing the D816V Mutation |
- Patients With Mastocytosis With Handicap and Bearing Mutations Asp-816-Val (D816V)
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
21 |
All |
18 Years and older (Adult, Senior) |
NCT01266369 |
AB06013 |
|
February 2007 |
November 2007 |
May 2010 |
December 24, 2010 |
December 24, 2010 |
|
|
| 18 |
NCT00001356 |
Completed |
Characteristics of Mast Cells in Mastocytosis |
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
300 |
All |
Child, Adult, Senior |
NCT00001356 |
930136
93-I-0136 |
|
May 1993 |
|
May 2002 |
November 4, 1999 |
March 4, 2008 |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States
|
| 19 |
NCT00006413 |
Completed |
Stem Cell Transplantation to Treat Systemic Mastocytosis |
|
- Procedure: Stem cell transplantation
|
Interventional |
Phase 2 |
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
25 |
All |
2 Years to 80 Years (Child, Adult, Senior) |
NCT00006413 |
010010
01-H-0010 |
|
October 13, 2000 |
|
December 14, 2006 |
October 18, 2000 |
July 2, 2017 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 20 |
NCT00918931 |
Terminated
Has Results |
Obatoclax for Systemic Mastocytosis |
- Leukemia
- Systemic Mastocytosis
|
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
- Gemin X
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
3 |
All |
18 Years and older (Adult, Senior) |
NCT00918931 |
2008-0792 |
|
June 2009 |
October 2010 |
October 2010 |
June 11, 2009 |
November 4, 2011 |
April 25, 2011 |
- UT MD Anderson Cancer Center
Houston, Texas, United States
|
| 21 |
NCT03401060 |
Recruiting |
Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis |
- Osteoporosis
- Systemic Mastocytosis
|
- Drug: Denosumab
- Drug: Placebo
|
Interventional |
Phase 3 |
- Assistance Publique - Hôpitaux de Paris
- CEREMAST
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Analysis of the lumbar spine bone mineral density (BMD)
- Occurrence of a low energy vertebral fracture and non vertebral fracture
- BMD at the total left hip
- (and 5 more...)
|
90 |
All |
18 Years and older (Adult, Senior) |
NCT03401060 |
P150918J
2016-000596-25 |
DenosuMast |
March 2, 2018 |
March 30, 2021 |
March 30, 2023 |
January 17, 2018 |
April 17, 2018 |
|
- Jean Minjoz Hospital, Dermatology department
Besançon, France - Caen Hospital, Clinical haematology department
Caen, France - Estaing Hospital, Cellular therapy and clinical haematology department
Clermont-Ferrand, France - (and 8 more...)
|
| 22 |
NCT02808793 |
Recruiting |
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK002 |
- Indolent Systemic Mastocytosis
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To evaluate the safety and tolerability by evaluating Clinical laboratory parameters and adverse events assessed using the CTCAE version 4
- Evaluate PK of AK002 in patients with ISM
- Evaluate the change from baseline in absolute peripheral counts of eosinophils and basophils.
- (and 3 more...)
|
30 |
All |
18 Years to 65 Years (Adult) |
NCT02808793 |
AK002-001 |
|
June 2016 |
September 2018 |
December 2018 |
June 22, 2016 |
December 20, 2017 |
|
- Charité - Universitätsmedizin Berlin
Berlin, Germany
|
| 23 |
NCT00047918 |
Completed |
Blood Factors in Mastocytosis and Unexplained Anaphylaxis and Flushing |
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
100 |
All |
Child, Adult, Senior |
NCT00047918 |
030010
03-I-0010 |
|
October 2002 |
|
August 2004 |
October 23, 2002 |
March 4, 2008 |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States
|
| 24 |
NCT00493129 |
Completed |
Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM) |
- Leukemia
- Systemic Mastocytosis
|
- Drug: Ontak (Denileukin Diftitox)
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
8 |
All |
Child, Adult, Senior |
NCT00493129 |
2004-0142 |
|
July 2004 |
August 2007 |
August 2007 |
June 28, 2007 |
February 8, 2012 |
|
- The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
|
| 25 |
NCT02415608 |
Terminated |
Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis |
- Aggressive Systemic Mastocytosis
- Mast Cell Leukemia
- Systemic Mastocytosis
|
- Drug: Ibrutinib
- Other: Quality-of-Life Assessment
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Studies
|
Interventional |
Phase 2 |
- Jason Robert Gotlib
- National Cancer Institute (NCI)
- Stanford University
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (rate of complete + partial remissions + CI)
- Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria version 4.03
- PK profiles of ibrutinib
- (and 8 more...)
|
4 |
All |
18 Years and older (Adult, Senior) |
NCT02415608 |
HEMMPD0021
NCI-2014-02341
P30CA124435 |
|
March 2015 |
March 14, 2017 |
June 14, 2017 |
April 14, 2015 |
November 21, 2017 |
|
- Stanford University Hospitals and Clinics
Stanford, California, United States
|
| 26 |
NCT02761473 |
Recruiting |
Cutaneous Mastocytosis in Children: Analysis of Somatic and Germline Mutations |
- Urticaria Pigmentosa
- Cutaneous Mastocytosis
|
- Other: skin biopsy
- Other: blood draw
|
Observational |
|
- University of Minnesota - Clinical and Translational Science Institute
|
Other |
- Observational Model: Family-Based
- Time Perspective: Prospective
|
- RNA sequencing
- SNP microarray analysis
|
50 |
All |
3 Months to 23 Years (Child, Adult) |
NCT02761473 |
19591 |
|
November 2016 |
June 2018 |
December 2018 |
May 4, 2016 |
March 14, 2017 |
|
- University of Minnesota
Minneapolis, Minnesota, United States
|
| 27 |
NCT01807598 |
Completed |
Brentuximab Vedotin in Treating Patients With Advanced Systemic Mastocytosis or Mast Cell Leukemia |
- Aggressive Systemic Mastocytosis
- Mast Cell Leukemia
- Systemic Mastocytosis
|
- Drug: brentuximab vedotin
|
Interventional |
Phase 2 |
- Jason Robert Gotlib
- National Cancer Institute (NCI)
- Stanford University
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate per consensus international response criteria (rate of complete or partial remissions or clinical improvement)
- Immunohistochemical expression of CD30 on neoplastic mast cells in core biopsy samples by flow cytometry
- Total symptom score using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)
- (and 5 more...)
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT01807598 |
HEMMPD0016
NCI-2013-00537
IRB-25727
107011 |
|
September 2013 |
December 2017 |
December 2017 |
March 8, 2013 |
February 19, 2018 |
|
- Stanford University, School of Medicine
Stanford, California, United States - MD Anderson Cancer Center
Houston, Texas, United States
|
| 28 |
NCT02380222 |
Completed |
Patient-Reported Outcome Questionnaire for Systemic Mastocytosis |
- Aggressive Systemic Mastocytosis (ASM)
- SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD)
- Mast Cell Leukemia (MCL)
- (and 2 more...)
|
|
Observational |
|
- Adelphi Values LLC
- Blueprint Medicines Corporation
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Collection of qualitative interview data on the symptoms of advanced systemic mastocytosis
|
5 |
All |
18 Years and older (Adult, Senior) |
NCT02380222 |
BL7064A |
|
July 2014 |
December 2015 |
December 2015 |
March 5, 2015 |
January 10, 2017 |
|
- Adelphi Values LLC
Boston, Massachusetts, United States
|
| 29 |
NCT00814073 |
Unknown † |
A Phase 3 Study to Compare Efficacy and Safety of Masitinib to Placebo in the Treatment of Patients With Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis With Handicap |
- Smouldering Systemic Mastocytosis
- Indolent Systemic Mastocytosis
- Cutaneous Mastocytosis With Handicap
- Mastocytosis
|
- Drug: masitinib (AB1010)
- Drug: placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Responder rate at week 24
- Response in mastocytosis variables (pruritus, flushes, depression or asthenia), mictions and stools per day, patient score and assessments, patients without handicap, mast cell infiltration , serum tryptase level, safety profile
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT00814073 |
AB06006 |
|
December 2008 |
December 2012 |
June 2013 |
December 23, 2008 |
September 26, 2012 |
|
- UC Davis Health System , Department of Dermatology
Sacramento, California, United States - MD Anderson Cancer Centre
Houston, Texas, United States - CHU d'Amiens
Amiens, France - (and 21 more...)
|
| 30 |
NCT00044122 |
Recruiting |
Study of Factors Regulating Mast Cell Proliferation |
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
- Date that the final subject will be examined or an intervention received for the purposes of final collection of data for the primary outcome
|
550 |
All |
2 Years to 80 Years (Child, Adult, Senior) |
NCT00044122 |
020277
02-I-0277 |
|
August 16, 2002 |
|
|
August 19, 2002 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 31 |
NCT02561988 |
Recruiting |
Study of BLU-285 in Patients With Advanced Systemic Mastocytosis (advSM) and Relapsed or Refractory Myeloid Malignancies |
- Aggressive Systemic Mastocytosis
- Systemic Mastocytosis-associated Hematologic Non-mast Cell Disease
- Mast Cell Leukemia
- Relapsed or Refractory Myeloid Malignancies
|
|
Interventional |
Phase 1 |
- Blueprint Medicines Corporation
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD) of avapritinib (also known as BLU-285)
- Number of patients with adverse and serious adverse events and changes in physical findings, vital signs, clinical laboratory results and ECG findings
- Recommended Phase 2 dose (RP2D) of avapritinib
- (and 7 more...)
|
65 |
All |
18 Years and older (Adult, Senior) |
NCT02561988 |
BLU-285-2101
2015-001661-12 |
|
December 2015 |
April 2019 |
May 2019 |
September 29, 2015 |
February 26, 2018 |
|
- Stanford Cancer Institute
Stanford, California, United States - University of Colorado Cancer Center
Denver, Colorado, United States - Emory University
Atlanta, Georgia, United States - (and 8 more...)
|
| 32 |
NCT00001760 |
Completed |
Cytokine Production Patterns in Patients With Systemic Mastocytosis Compared With Atopic Dermatitis and Healthy Individuals |
- Atopic Dermatitis
- Healthy
- Mastocytosis
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
40 |
All |
Child, Adult, Senior |
NCT00001760 |
980049
98-I-0049 |
|
January 1998 |
|
December 2001 |
November 4, 1999 |
December 13, 2007 |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States
|
| 33 |
NCT00233454 |
Active, not recruiting
Has Results |
Phase II Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia |
- Systemic Mastocytosis, Aggressive (ASM)
- Leukemia, Mast Cell
- Hematological Non-mast Cell Lineage Disease (AHNMD)
|
|
Interventional |
Phase 2 |
- Jason Robert Gotlib
- Novartis
- Novartis Pharmaceuticals
- Stanford University
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Subjects With Clinical Response [Partial Response (PR) + Complete Response (CR)]
- Overall Survival (OS)
|
26 |
All |
18 Years and older (Adult, Senior) |
NCT00233454 |
IRB-13704
95242
HEMMPD0003
CPKC412D2201
2213 |
|
March 2005 |
June 21, 2010 |
December 2017 |
October 5, 2005 |
July 26, 2017 |
July 9, 2015 |
- Stanford University School of Medicine
Stanford, California, United States - Dana Farber Cancer Institute
Boston, Massachusetts, United States - Washington University-St. Louis
Saint Louis, Missouri, United States
|
| 34 |
NCT00769587 |
Completed |
Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis |
- Non Neoplastic Condition
- Precancerous Condition
|
|
Interventional |
Phase 2 |
- Centre Hospitalier Universitaire, Amiens
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective reduction of the infiltration rate at 6 months
|
20 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00769587 |
PI06-DR-DAMAJ
CHU-AMIENS-PI06
EUDRACT-2006-005087-10
INCA-RECF0510 |
|
June 2007 |
May 2011 |
October 2012 |
October 9, 2008 |
April 26, 2016 |
|
- Centre Hospitalier Universitaire d'Amiens
Amiens, France
|
| 35 |
NCT00001756 |
Recruiting |
Study of Mast Cell Precursors |
- Normal Physiology
- Systemic Mastocytosis
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- 1. Use of G-CSF administration in healthy volunteers to mobilize and enhance CD34+ hematopoietic progenitor cell numbers into the peripheral blood in order to culture and characterize human mast cells, study and characterize CD34+ -derived human...
- 2. Use of Plerixafor administration in patients with systemic mastocytosis and other related allergic, hematological and immunological conditions to mobilize and enhance CD34+ cells into the peripheral blood to culture and learn how mast cells c...
|
300 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00001756 |
980027
98-I-0027 |
|
November 12, 1997 |
|
|
November 4, 1999 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 36 |
NCT00038675 |
Completed |
Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate |
- Chronic Myelomonocytic Leukemia
- Chronic Myeloid Leukemia
- Polycythemia Vera
- (and 2 more...)
|
- Drug: Imatinib Mesylate (Gleevec)
|
Interventional |
Not Applicable |
- M.D. Anderson Cancer Center
- Novartis Pharmaceuticals
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective response rate
- Duration of response and survival
|
125 |
All |
Child, Adult, Senior |
NCT00038675 |
ID01-167 |
|
June 2001 |
November 2013 |
November 2013 |
June 5, 2002 |
December 12, 2013 |
|
- UT MD Anderson Cancer Center
Houston, Texas, United States
|
| 37 |
NCT01326741 |
Unknown † |
Clonal Mast Cell Disorders in Exercise-Induced Anaphylaxis |
|
|
Observational |
|
- Brigham and Women's Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Number of participants with presence of clonal abnormalities in the bone marrow specimen
|
10 |
All |
21 Years and older (Adult, Senior) |
NCT01326741 |
2010P002042 |
|
March 2011 |
|
|
March 31, 2011 |
March 31, 2011 |
|
- Brigham and Women's Hospital
Boston, Massachusetts, United States
|
| 38 |
NCT00782067 |
Active, not recruiting
Has Results |
Efficacy and Safety of Midostaurin in Patients With Aggressive Systemic Mastocytosis or Mast Cell Leukemia |
|
- Drug: Midostaurin (PKC412)
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate (ORR)
- Duration of Response
- Time to Response
- Overall Survival (OS)
|
116 |
All |
18 Years and older (Adult, Senior) |
NCT00782067 |
CPKC412D2201
2008-000280-42 |
|
October 15, 2008 |
December 1, 2014 |
July 12, 2017 |
October 29, 2008 |
June 6, 2017 |
June 6, 2017 |
- University of California at Los Angeles Dept. of Hematology Clinic
Los Angeles, California, United States - Stanford University Medical Center Stanford University 2
Stanford, California, United States - University of Colorado Dept of Univ. of Colorado
Aurora, Colorado, United States - (and 28 more...)
|
| 39 |
NCT00132015 |
Completed |
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis |
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- (and 2 more...)
|
|
Interventional |
Phase 2 |
- National Institutes of Health Clinical Center (CC)
- National Cancer Institute (NCI)
|
NIH |
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective response (complete and partial response)
- Quality of life as assessed by the European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at baseline and prior to each treatment course
|
37 |
All |
18 Years and older (Adult, Senior) |
NCT00132015 |
060076
06-C-0076
NCI-6454
NCI-P6175
CDR0000438778 |
|
May 2006 |
December 2007 |
June 2008 |
August 19, 2005 |
March 15, 2012 |
|
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States - NCI - Center for Cancer Research
Bethesda, Maryland, United States
|
| 40 |
NCT02268253 |
Recruiting |
SL-401 in Advanced, High Risk Myeloproliferative Neoplasms (Systemic Mastocytosis, Advanced Symptomatic Hypereosinoophic Disorder, Myelofibrosis, Chronic Myelomonocytic Leukemia) |
- Myelofibrosis
- Chronic Myelomonocytic Leukemia
|
|
Interventional |
Phase 1
Phase 2 |
- Stemline Therapeutics, Inc.
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02268253 |
STML-401-0314 |
|
December 2014 |
December 2018 |
June 2019 |
October 20, 2014 |
January 29, 2018 |
|
- City of Hope
Duarte, California, United States - University of California, Los Angeles
Los Angeles, California, United States - University of Kansas Cancer Center
Westwood, Kansas, United States - (and 8 more...)
|
| 41 |
NCT02571036 |
Recruiting |
A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies |
- Gastrointestinal Stromal Tumors
- Aggressive Systemic Mastocytosis
- Advanced Cancers
|
|
Interventional |
Phase 1 |
- Deciphera Pharmaceuticals LLC
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose limiting toxicities, AEs, SAEs, discontinuation of drug due to toxicity, physical exams and ECOG PS, ophthalmologic examinations, changes from baseline in laboratory parameters, electrocardiograms, LVEF, and vital signs.
- Determination of the Maximum Tolerated Dose and the Recommended Phase 2 Dose
- Maximum plasma concentration of DCC-2618 (Tmax)
- (and 12 more...)
|
250 |
All |
18 Years and older (Adult, Senior) |
NCT02571036 |
DCC-2618-01-001 |
|
October 2015 |
June 2018 |
December 2018 |
October 8, 2015 |
January 31, 2018 |
|
- Honor Health
Scottsdale, Arizona, United States - UCLA (malignant gliomas only)
Los Angeles, California, United States - Stanford (GIST & mastocytosis only)
Palo Alto, California, United States - (and 14 more...)
|
| 42 |
NCT02503800 |
Recruiting |
The Significance of Blood-tryptase and c-Kit Mutation in Insect Venom Immunotherapy |
- Hypersensitivity, Immediate
- Insect Bites and Stings
- Mastocytosis
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The association between tryptase values/c-Kit mutation and immunotherapy adverse events will be evaluated using blood sample analysis and patient medical records.
- The association between tryptase values/c-Kit mutation and severity of index sting event will be evaluated using blood sample analysis and patient medical records.
|
200 |
All |
4 Years to 75 Years (Child, Adult, Senior) |
NCT02503800 |
MMC150100-15CTIL |
|
August 2015 |
August 2018 |
August 2018 |
July 21, 2015 |
March 16, 2018 |
|
- Meir Medical Center
Kfar Saba, Israel
|
| 43 |
NCT00255346 |
Completed |
Dasatinib as Therapy for Myeloproliferative Disorders (MPDs) |
- Acute Myeloid Leukemia
- Myelodysplastic Syndromes
- Agnogenic Myeloid Metaplasia
- (and 5 more...)
|
- Drug: Dasatinib (BMS-354825)
|
Interventional |
Phase 2 |
- M.D. Anderson Cancer Center
- Bristol-Myers Squibb
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Participant Response Rate
- Duration of Response (Survival)
|
68 |
All |
18 Years and older (Adult, Senior) |
NCT00255346 |
2004-0817
NCI-2012-01353 |
|
November 15, 2005 |
March 3, 2017 |
March 3, 2017 |
November 18, 2005 |
March 9, 2017 |
|
- The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
|
| 44 |
NCT00171912 |
Completed |
Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes |
- Hypereosinophilic Syndrome
- Systemic Mastocytosis
- Chronic Myelomonocytic Leukemia
- Dermatofibrosarcoma
|
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To assess the efficacy and the safety of imatinib mesylate therapy
- To evaluate the effects of imatinib on quality of life and healthcare resource use
|
38 |
All |
16 Years to 80 Years (Child, Adult, Senior) |
NCT00171912 |
CSTI571BAU12 |
|
September 2004 |
January 2012 |
January 2012 |
September 15, 2005 |
February 23, 2017 |
|
- Novartis Investigative Site
East Melbourne, Australia
|
| 45 |
NCT00109707 |
Completed |
A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Blood Related Cancers |
- Chronic Myelogenous Leukemia
- Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)
- Hypereosinophilic Syndrome
- Systemic Mastocytosis
|
|
Interventional |
Phase 1
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- • To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of AMN107 as a single agent when administered as an oral once-daily and twice daily dose to adult patients with imatinib-resistant CML (phase l)
- • To characterize the pharmacokinetic profile of AMN107 in serum and, where samples are available, in tumor cells and normal hematopoietic cells. (phase l)
- • To evaluate the efficacy and safety of AMN107 in patients with imatinib-resistant or intolerant CML-BC, imatinib-resistant or intolerant CML-AP and imatinib-resistant or intolerant CML-CP. (phase ll)
- (and 5 more...)
|
942 |
All |
18 Years and older (Adult, Senior) |
NCT00109707 |
CAMN107A2101 |
|
May 2004 |
September 2012 |
September 2012 |
May 3, 2005 |
April 29, 2016 |
|
- City of Hope National Medical Center
Duarte, California, United States - Stanford University Medical Center
Stanford, California, United States - University of Colorado Hospital
Aurora, Colorado, United States - (and 98 more...)
|
| 46 |
NCT03406325 |
Not yet recruiting |
Mast Cell Activation Test in Allergic Disease |
- Asthma
- Mastocytosis
- Mast Cell Activation Syndrome
- (and 4 more...)
|
|
Observational |
|
- Hong Kong Sanatorium & Hospital
- Chinese University of Hong Kong
- Stanford University
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Correlation of genomic analyses with mediator release and specific diagnosis
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03406325 |
REC-2017-17 |
|
February 2018 |
January 2019 |
June 2019 |
January 23, 2018 |
January 23, 2018 |
|
|
| 47 |
NCT03214666 |
Not yet recruiting |
CD16/IL-15/CD33 Tri-Specific Killer Engagers (TriKes) for CD33+ Hem Malignancies |
- High-risk Myelodysplastic Syndromes
- Acute Myelogenous Leukemia
- Acute Lymphoblastic Leukemia
- (and 2 more...)
|
- Drug: 161533 with Bolus Test Dose
- Drug: 161533 Only
|
Interventional |
Phase 1
Phase 2 |
- Masonic Cancer Center, University of Minnesota
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I Maximum Tolerated Dose (MTD) of 161533 TriKE Finding
- Incidence of complete and partial remission due to 161533 TriKE treatment
- Incidence of 161533 TriKE Treatment-Emergent Adverse Events [Safety and Tolerability]
- Overall Survival (OS)
|
60 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03214666 |
2015LS167 |
|
November 1, 2018 |
December 1, 2022 |
June 1, 2023 |
July 11, 2017 |
December 5, 2017 |
|
- Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
|
| 48 |
NCT00557895 |
Enrolling by invitation |
Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders |
- Allergy
- Asthma
- Allergic Rhinitis
- (and 3 more...)
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The protocol serves to evaluate and provide long term follow up of patients with allergic, hypersensitivity and inflammatory disorders for the purposes of maintaining a group of patients from which LAD investigators may draw for other protocols ...
|
288 |
All |
3 Years to 80 Years (Child, Adult, Senior) |
NCT00557895 |
960129
96-I-0129 |
|
August 26, 1996 |
|
|
November 14, 2007 |
April 20, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 49 |
NCT02760238 |
Recruiting |
Myeloproliferative Neoplasms (MPNs) Patient Registry |
- Primary Myelofibrosis
- Polycythemia Vera
- Essential Thrombocythemia
- (and 7 more...)
|
|
Observational |
|
- University Health Network, Toronto
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Survival
- General patient characteristics will be captured from the Hematologic Malignacy tissue bank
- Disease risk score
- (and 14 more...)
|
5000 |
All |
Child, Adult, Senior |
NCT02760238 |
UHN REB 15-9814 CE |
|
April 2016 |
October 2025 |
October 2025 |
May 3, 2016 |
October 31, 2017 |
|
- Princess Margaret Cancer Centre
Toronto, Ontario, Canada
|
| 50 |
NCT03340155 |
Recruiting |
Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases |
- Psoriasis
- Cutaneous T Cell Lymphoma
- Lymphoproliferative Disorders
- (and 8 more...)
|
- Other: Photo(chemo)therapy
|
Interventional |
Not Applicable |
- Medical University of Graz
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Correlation of soluble factors in the serum with clinical response, as measured by disease severity
- Correlation of cellular markers of peripheral lymphocytes with clinical response, as measured by disease severity
- Evaluation of T cell receptor repertoire
- (and 3 more...)
|
240 |
All |
18 Years and older (Adult, Senior) |
NCT03340155 |
Graz IRB# 29-609 ex 16/17 |
BioUV2017 |
October 30, 2017 |
October 2022 |
October 2022 |
November 13, 2017 |
November 13, 2017 |
|
- Medical University of Graz, Department of Dermatology
Graz, Styria, Austria
|
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