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This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. The study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nelarabine | nelarabine 650mg/m2 IV daily for 5 days. repeat every 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nelarabine | Drug | Nelarabine is a prodrug of 9-β-D-arabinofuranosylguanine (ara-G), a deoxyguanosine analogue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurological adverse events | Up to one year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Other adverse events | Up to one year after treatment | |
| clinical response rate and survival | one year |
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Inclusion Criteria:
Exclusion Criteria:
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Male or Female 21 years or younger with Relapsed or refractory T-lineage Acute Lymphoblastic Leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL)
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aahur N | Denmark | ||||
| GSK Investigational Site |
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| Aalborg |
| DK-9100 |
| Denmark |
| GSK Investigational Site | Koebenhavn Oe | 2100 | Denmark |
| GSK Investigational Site | Odense C | Denmark |
| GSK Investigational Site | Bordeaux | 33076 | France |
| GSK Investigational Site | Lille | 59037 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Paris | 75475 | France |
| GSK Investigational Site | Paris | 75571 | France |
| GSK Investigational Site | Paris | 75935 | France |
| GSK Investigational Site | Vandœuvre-lès-Nancy | 54511 | France |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45122 | Germany |
| GSK Investigational Site | Beersheba | 84101 | Israel |
| GSK Investigational Site | Haifa | 31096 | Israel |
| GSK Investigational Site | Petah Tikva | Israel |
| GSK Investigational Site | Ramat Gan | 52621 | Israel |
| GSK Investigational Site | Bologna | Emilia-Romagna | 40137 | Italy |
| GSK Investigational Site | Rotterdam | 3015 GJ | Netherlands |
| GSK Investigational Site | Bydgoszcz | Poland |
| GSK Investigational Site | Lublin | 20-093 | Poland |
| GSK Investigational Site | Warsaw | 00-576 | Poland |
| GSK Investigational Site | Warsaw | 02-781 | Poland |
| GSK Investigational Site | Wroclaw | 50-345 | Poland |
| GSK Investigational Site | Krasnodar | 350007 | Russia |
| GSK Investigational Site | Moscow | 117997 | Russia |
| GSK Investigational Site | Moscow | 119049 | Russia |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Boadilla Del Monte (Madrid) | 28660 | Spain |
| GSK Investigational Site | Madrid | 28009 | Spain |
| GSK Investigational Site | Madrid | 28047 | Spain |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C104457 | nelarabine |
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