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| ID | Type | Description | Link |
|---|---|---|---|
| CHU-AMIENS-PI06 | |||
| EUDRACT-2006-005087-10 | |||
| INCA-RECF0510 |
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RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to the disease.
PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with relapsed or progressive systemic mastocytosis.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily for 6 months in the absence of disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thalidomide | Experimental | Use of thalidomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thalidomide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective reduction of the infiltration rate at 6 months | 6 months |
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DISEASE CHARACTERISTICS:
Diagnosis of systemic mastocytosis
Measurable or evaluable disease
Presence of c-Kit D816V mutation in the skin, spine, or infiltrated organs
No nonsymptomatic mastocytosis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Gandhi Damaj | Centre Hospitalier Universitaire, Amiens | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Amiens | Amiens | 80054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23432617 | Result | Gruson B, Lortholary O, Canioni D, Chandesris O, Lanternier F, Bruneau J, Grosbois B, Livideanu C, Larroche C, Durieu I, Barete S, Sevestre H, Diouf M, Chaby G, Marolleau JP, Dubreuil P, Hermine O, Damaj G. Thalidomide in systemic mastocytosis: results from an open-label, multicentre, phase II study. Br J Haematol. 2013 May;161(3):434-42. doi: 10.1111/bjh.12265. Epub 2013 Feb 22. |
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| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D034721 | Mastocytosis, Systemic |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008415 | Mastocytosis |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| D009370 | Neoplasms by Histologic Type |
| D000090362 | Mast Cell Activation Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |