Alkeran (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 28 | 全身性アミロイドーシス | 5 |
| 60 | 再生不良性貧血 | 1 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2010-022395-31-CZ (EUCTR) | 01/10/2013 | 17/07/2013 | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis. | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis. | AL Amyloidosis MedDRA version: 16.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: VELCADE INN or Proposed INN: BORTEZOMIB Trade Name: ALKERAN Product Name: Melphalan INN or Proposed INN: MELPHALAN Trade Name: FORTECORTIN Product Name: dexamethasone Product Code: A01AC02 INN or Proposed INN: DEXAMETHASONE | E.M.N. - EUROPEAN MYELOMA NETWORK | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | United States;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 2 | EUCTR2010-022395-31-DE (EUCTR) | 25/10/2012 | 18/10/2012 | Clinical trial of Melphalan and Dexamethasone versus Bortezomib, Melphalan and Dexamethasone for untreated patients with systemic light-chain (AL) amyloidosis | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - AC-004-EU | AL amyloidosis MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Velcade INN or Proposed INN: BORTEZOMIB Trade Name: Fortecortin Product Name: Dexamethason INN or Proposed INN: Dexamethasone Other descriptive name: DEXAMETHASONE Trade Name: Alkeran Product Name: Melphalan INN or Proposed INN: MELPHALAN | European Myeloma Network | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | France;Czech Republic;Greece;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 3 | EUCTR2010-022395-31-GR (EUCTR) | 02/05/2012 | 02/04/2012 | N/A | N/A - BMDex vs MDex for AL amyloidosis | Primary Systemic (AL) Amyloidosis MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: VELCADE INN or Proposed INN: BORTEZOMIB Trade Name: Dexaton INN or Proposed INN: Dexamethasone Other descriptive name: DEXAMETHASONE Trade Name: Alkeran INN or Proposed INN: MELPHALAN Trade Name: Dexaton INN or Proposed INN: Dexamethasone Other descriptive name: DEXAMETHASONE Trade Name: Alkeran INN or Proposed INN: MELPHALAN | European Myeloma Network | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | United Kingdom;Denmark;Spain;Italy;Greece;Sweden;Australia | |||
| 4 | EUCTR2010-022395-31-DK (EUCTR) | 14/11/2011 | 09/06/2011 | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis | A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis | AL Amyloidosis MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: VELCADE Product Name: bortezomib Product Name: Dexamethasone Trade Name: Alkeran Product Name: Melphalan Product Name: Dexamethasone Product Name: Melphalan | E.M.N. - EUROPEAN MYELOMA NETWORK | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Czech Republic;Greece;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2008-001405-41-DE (EUCTR) | 24/10/2008 | 28/08/2008 | A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX | A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX | AL amyloidosis | Trade Name: Revlimid Other descriptive name: Lenalidomide Trade Name: Alkeran Product Code: L01AA03 Other descriptive name: melphalan Trade Name: Fortecortin Other descriptive name: dexamethasone | GMIHO mbH | NULL | Not Recruiting | Female: yes Male: yes | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2007-001657-26-GB (EUCTR) | 29/02/2008 | 07/11/2007 | Single Centre Phase II Pilot study of Unrelated Cord Blood Transplantation in Patients with Poor Risk Haematological Malignancies. | Single Centre Phase II Pilot study of Unrelated Cord Blood Transplantation in Patients with Poor Risk Haematological Malignancies. | 1.Acute, chronic leukaemia or myelodysplastic syndrome for which allogeneic transplantation is considered as the best treatment option. 2.Acute lymphoblastic leukaemia (ALL)3.Non-Hodgkin’s lymphoma4.Hodgkin’s disease5.Chronic lymphocytic leukaemia. 6.Acquired bone marrow failure syndromes7.Other haematological malignancies for which UD bone marrow transplantation is indicated MedDRA version: 9.1;Level: LLT;Classification code 10000880;Term: Acute myeloid leukaemia MedDRA version: 9.1;Classification code 10028533;Term: Myelodysplastic syndrome MedDRA version: 9.1;Classification code 10009013;Term: Chronic myeloid leukaemia MedDRA version: 9.1;Classification code 10000844;Term: Acute lymphoblastic leukaemia MedDRA version: 9.1;Classification code 10020328;Term: Hodgkin's lymphoma MedDRA version: 9.1;Classification code 10029593;Term: Non-Hodgkin's lymphoma NOS MedDRA version: 9.1;Classification code 10003892;Term: B-cell chronic lymphocytic leukaemia/prolymphocytic leukaemia/small lymphocytic lymphoma MedDRA version: 9.1;Classification code 10002968;Term: Aplastic anaemia, unspecified | Trade Name: Fludarabine INN or Proposed INN: FLUDARABINE PHOSPHATE Trade Name: Busilvex INN or Proposed INN: BUSULFAN Trade Name: Thymoglobulin Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN Trade Name: Thiotepa INN or Proposed INN: THIOTEPA Trade Name: Cyclophosphamide Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE Trade Name: Alkeran INN or Proposed INN: MELPHALAN | King's College Hospital NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 27 | Phase 2 | United Kingdom |