Ignite Creation Date:
2024-05-05 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00656812
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2008-04-02
Brief Title:
Rituximab Plus 2CdA in Patients With Advanced or Relapsed Mucosa Associated Lymphoid Tissue MALT Lymphoma
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Organization:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study Overview
Official Title:
Phase II Trial of Rituximab Plus 2CdA in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue MALT
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to evaluate whether a Rituximab plus 2 CdA combination therapy is effective and safe in the treatment of patients with advanced or relapsed lymphoma of the mucosa associated lymphoid tissue MALT
Detailed Description:
Currently there is no chemotherapeutic standard treatment for patients with MALT lymphoma either presenting with disseminated disease or with relapsingrefractory disease following local treatment including radiation or eradication of HP Various compounds have been tested including alkylating agents such as cyclophosphamide or chlorambucil the nucleoside analog cladribine 2CdA as well as combination regimens including CHOP or MCP mitoxantrone chlorambucil prednisone but only limited data exists from prospective trials Thus trials to evaluate the potential of new compounds in patients with advanced MALT lymphoma are not only justified but seem warranted
While systemic approaches were until recently thought to be justified only in patients with disseminated disease emerging data suggest that also patients with localized disease potentially amenable to radiation may benefit from systemic treatment This has been demonstrated for ocular adnexal MALT lymphoma and recently also for gastric MALT lymphoma in a randomized fashion where application of chemotherapy resulted in a significantly longer time to relapse as opposed to surgery or radiation without impairing overall survival
Both 2CdA and rituximab have been demonstrated as active single agents in MALT lymphoma with mild toxicity profiles and no data on combination therapy with rituximab plus chemotherapy in MALT lymphoma have been published to date This study will therefore evaluate the efficacy and safety of Rituximab plus 2CdA in patients with advanced or relapsed lymphoma of the mucose associated lymphoid tissue
While systemic approaches were until recently thought to be justified only in patients with disseminated disease emerging data suggest that also patients with localized disease potentially amenable to radiation may benefit from systemic treatment This has been demonstrated for ocular adnexal MALT lymphoma and recently also for gastric MALT lymphoma in a randomized fashion where application of chemotherapy resulted in a significantly longer time to relapse as opposed to surgery or radiation without impairing overall survival
Both 2CdA and rituximab have been demonstrated as active single agents in MALT lymphoma with mild toxicity profiles and no data on combination therapy with rituximab plus chemotherapy in MALT lymphoma have been published to date This study will therefore evaluate the efficacy and safety of Rituximab plus 2CdA in patients with advanced or relapsed lymphoma of the mucose associated lymphoid tissue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2008-000767-41 | None | None | None |