11 completed, 3 terminated, 2 recruiting, 2 unknown. 12 Phase 2, 3 Phase 1, 2 Phase 3, 1 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 6, Terminated 3, Unknown 2, Withdrawn 1 |
| Phase 1 | 3 | Completed 2, Terminated 1 |
| Phase 3 | 2 | Completed 1, Unknown 1 |
| Not applicable | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow Systemic Mastocytosis: new trials by email Literature Review of Systemic Mastocytosis trials Research Report on Systemic Mastocytosis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Precision Medicine for Indolent Systemic Mastocytosis (PRISM) Systemic Mastocytosis | Not yet recruiting | Mayo Clinic | 25 | 2026-09-09 | 2026-08-18 | |
| Peripheral Blood KIT-D816V Mutation in Adult Systemic Mastocytosis Systemic Mastocytosis, KIT-D816V Mutation | Recruiting | The First Affiliated Hospital of Soochow University | 50 | 2025-05-19 | 2026-05-01 | |
| Mastocytosis From Pediatric Age to Adulthood: Local Registry of Cutaneous and Systemic Mastocytosis Cutaneous Mastocytosis, Systemic Mastocytosis | Recruiting | Fondazione IRCCS Policlinico San Matteo di Pavia | 600 | 2024-01-26 | 2025-08-26 | |
| Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies Acetaminophen, Dexamethasone, Diphenhydramine - Recurrent Acute Leukemia, Recurrent B Acute Lymphoblastic Leukemia | Phase 1 | Completed | City of Hope Medical Center | 13 | 2020-11-18 | 2026-01-28 |
| Flotetuzumab in Treating Patients With Recurrent or Refractory CD123 Positive Blood Cancer Anti-CD123/CD3 Monoclonal Antibody MGD006 - Acute Biphenotypic Leukemia, Acute Leukemia | Phase 2 | Withdrawn | City of Hope Medical Center | 2020-10-20 | 2020-12-17 | |
| GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies GTB-3550 TriKE® Phase I, GTB-3550 TriKE® Phase II - High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia | Phase 1 / Phase 2 | Terminated | GT Biopharma, Inc. | 12 | 2020-01-01 | 2022-11-10 |
| Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis Denosumab, Placebo - Osteoporosis, Systemic Mastocytosis | Phase 3 | Completed | Assistance Publique - Hôpitaux de Paris | 24 | 2018-03-05 | 2026-03-31 |
| Diagnostic Value of Bone Marrow Tryptase in Systemic Mastocytosis Mastocytosis diagnosis - Systemic Mastocytosis | Not applicable | Completed | University Hospital, Toulouse | 250 | 2015-10-06 | 2019-07-15 |
| Treatment of Indolent Systemic Mastocytosis With PA101 PA101, Placebo - Mastocytosis, Systemic Mastocytosis | Phase 2 | Completed | Patara Pharma | 41 | 2015-06-01 | 2016-09-29 |
| Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis Ibrutinib - Aggressive Systemic Mastocytosis, Mast Cell Leukemia | Phase 2 | Terminated | Jason Robert Gotlib | 4 | 2015-03-01 | 2018-09-20 |
| Brentuximab Vedotin in Treating Patients With Advanced Systemic Mastocytosis or Mast Cell Leukemia Brentuximab vedotin - Aggressive Systemic Mastocytosis, Mast Cell Leukemia | Phase 2 | Completed | Jason Robert Gotlib | 10 | 2013-09-01 | 2019-01-29 |
| Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis Cladribine and pegylated interpheron alpha-2a - Systemic Mastocytosis | Phase 2 / Phase 3 | Unknown | Hospital Virgen de la Salud | 10 | 2012-05-01 | 2016-08-29 |
| Imatinib in KIT-negative Systemic Mastocytosis Imatinib Mesylate - Systemic Mastocytosis | Phase 4 | Completed | Hospital Virgen de la Salud | 10 | 2011-01-01 | 2016-08-29 |
| Evaluation of Response of Dasatinib to Treat Mastocytosis Dasatinib - Systemic Mastocytosis | Phase 2 | Unknown | Federico II University | 30 | 2009-11-01 | 2009-09-18 |
| Obatoclax for Systemic Mastocytosis Obatoclax Mesylate - Leukemia, Systemic Mastocytosis | Phase 2 | Terminated | M.D. Anderson Cancer Center | 3 | 2009-06-01 | 2011-11-04 |
| Everolimus (RAD001) as Therapy for Patients With Systemic Mastocytosis RAD001 (Everolimus) - Systemic Mastocytosis | Phase 2 | Completed | M.D. Anderson Cancer Center | 10 | 2007-04-01 | 2026-07-06 |
| A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies Nilotinib - Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive) | Phase 1 / Phase 2 | Completed | Novartis Pharmaceuticals | 507 | 2005-04-01 | 2021-06-29 |
| Use of Tamoxifen in Systemic Mastocytosis Systemic Mastocytosis | Completed | Mayo Clinic | 1 | 2005-02-01 | 2020-04-10 | |
| Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes imatinib mesylate - Hypereosinophilic Syndrome, Systemic Mastocytosis | Phase 2 | Completed | Novartis Pharmaceuticals | 38 | 2004-09-01 | 2017-02-23 |
| Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM) Ontak (Denileukin Diftitox) - Leukemia, Systemic Mastocytosis | Phase 2 | Completed | M.D. Anderson Cancer Center | 8 | 2004-07-01 | 2012-02-08 |
Mastocytosis, Systemic (20) · Leukemia, Mast-Cell (4) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive (3) · Mastocytosis (3) · Blastic Plasmacytoid Dendritic Cell Neoplasm (2) · Hematologic Neoplasms (2) · Hodgkin Disease (2) · Hypereosinophilic Syndrome (2) · Leukemia (2) · Leukemia, Hairy Cell (2) · Mast Cell Activation Disorders (2) · Mastocytosis, Cutaneous (2) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (2) · Burkitt Lymphoma (1) · Dermatofibrosarcoma (1)
Immune System Diseases (20) · Neoplasms (20) · Neoplasms by Histologic Type (20) · Neoplasms, Connective Tissue (20) · Neoplasms, Connective and Soft Tissue (20) · Mast Cell Activation Disorders (18) · Mastocytosis (17) · Hematologic Diseases (9) · Hemic and Lymphatic Diseases (9) · Leukemia, Myeloid (8) · Leukemia (7) · Bone Marrow Diseases (5) · Neoplasms by Site (5) · Chronic Disease (4) · Disease Attributes (4)
Imatinib Mesylate (2) · Acetaminophen (1) · Brentuximab Vedotin (1) · Calcium Dobesilate (1) · Cladribine (1) · Dasatinib (1) · Denosumab (1) · Dexamethasone (1) · Diphenhydramine (1) · Everolimus (1) · Ibuprofen (1) · Ranitidine (1) · auricularum (1) · denileukin diftitox (1) · dexamethasone 21-phosphate (1)
M.D. Anderson Cancer Center (3) · City of Hope Medical Center (2) · Hospital Virgen de la Salud (2) · Jason Robert Gotlib (2) · Mayo Clinic (2) · Novartis Pharmaceuticals (2) · Assistance Publique - Hôpitaux de Paris (1) · Federico II University (1) · Fondazione IRCCS Policlinico San Matteo di Pavia (1) · GT Biopharma, Inc. (1) · Patara Pharma (1) · The First Affiliated Hospital of Soochow University (1) · University Hospital, Toulouse (1)
United States (10) · France (4) · Italy (4) · Spain (4) · Australia (2) · Germany (2) · Netherlands (2) · Austria (1) · Belgium (1) · Canada (1) · China (1) · Denmark (1) · Finland (1) · Hong Kong (1) · Martinique (1)
Srdan Verstovsek, MD (3) · Jason Gotlib (2) · Luis Escribano, MD, PhD (2) · Cristina Livideanu, MD (1) · Frank Siebenhaar, MD (1) · Ibrahim Aldoss, MD (1) · Ibrahim T Aldoss (1) · Joseph H Butterfield, MD (1) · Mark B Juckett, MD (1) · Massimo Triggiani, MD (1) · Olivier Hermine, MD (1) · Thanai Pongdee, MD (1)
PMID 15070706, PMID 16775235, PMID 17715389, PMID 18567837, PMID 21098399, PMID 23547655, PMID 24057647, PMID 26002753, PMID 31350306, PMID 35622074
2016 (1), P30CA033572 (1), P30CA124435 (1)