Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466258
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2007-04-25
Brief Title:
LINFOTARGAM Treatment With Chemotherapy Plus Rituximab and Highly Active Antiretroviral Therapy in Patients With Diffuse Large B Cell Lymphoma and Infection With the Human Immunodeficiency Virus HIV
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
LINFOTARGAM First-line Treatment With Dose-dense Chemotherapy Plus Rituximab R-CHOP14 and Highly Active Antiretroviral Therapy HAART in Patients With Diffuse Large B Cell Lymphoma DLBCL and Infection With the Human Immunodeficiency Virus HIV
Status:
COMPLETED
Status Verified Date:
2009-11
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:
LINFOTARGAM
Brief Summary:
Main objective
To evaluate the applicability of the treatment
1 To evaluate the treatment toxicity according to the Common Terminology Criteria CTC version 30 of the National Cancer Institute NCI
2 To evaluate opportunistic and non-opportunistic infections after 6 cycles of treatment with rituximab plus cyclophosphamide doxorubicin vincristine and prednisone R-CHOP administered every 14 days and highly active antiretroviral therapy HAART in patients with diffuse large B cell lymphoma DLBCL and HIV infection
3 To evaluate the adherence to the treatment with 6 cycles of R-CHOP considering the delays in the administration of the cycles and the reductions in the doses of chemotherapy planned dose administered in predicted term
Secondary objectives
To evaluate the efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days R-CHOP14
1 To determine the global response and complete remission tax
2 To evaluate the duration of the response
3 To evaluate the probability of event-free survival in 5 years
4 To evaluate the probability of global survival in 5 years
To identify predictive factors of response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection
To evaluate the impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection HIV viral load and CD4 lymphocyte count
To evaluate the applicability of the treatment
1 To evaluate the treatment toxicity according to the Common Terminology Criteria CTC version 30 of the National Cancer Institute NCI
2 To evaluate opportunistic and non-opportunistic infections after 6 cycles of treatment with rituximab plus cyclophosphamide doxorubicin vincristine and prednisone R-CHOP administered every 14 days and highly active antiretroviral therapy HAART in patients with diffuse large B cell lymphoma DLBCL and HIV infection
3 To evaluate the adherence to the treatment with 6 cycles of R-CHOP considering the delays in the administration of the cycles and the reductions in the doses of chemotherapy planned dose administered in predicted term
Secondary objectives
To evaluate the efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days R-CHOP14
1 To determine the global response and complete remission tax
2 To evaluate the duration of the response
3 To evaluate the probability of event-free survival in 5 years
4 To evaluate the probability of global survival in 5 years
To identify predictive factors of response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection
To evaluate the impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection HIV viral load and CD4 lymphocyte count
Detailed Description:
This is a clinical trial with a pharmaceutical drug used in the same conditions of authorization
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 |
|---|---|---|---|
| LINFOTARGAM | None | None | None |