Status:
COMPLETED
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)
Lead Sponsor:
PETHEMA Foundation
Conditions:
HIV Infections
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 3.0 of the National Cancer Instit...
Detailed Description
This is a clinical trial with a pharmaceutical drug used in the same conditions of authorization.
Eligibility Criteria
Inclusion
- Patients with HIV infection diagnosed with DLBCL in any stage (I-IV according to the Ann Arbor classification) not previously treated for the lymphoma.
- Patients with CD20-positive diffuse large B-cell lymphoma
- Aged from 18 to 70 years old
- Any score of International Prognostic Index. (It is also applicable in patients with non-Hodgkin lymphoma \[NHL\] infected with HIV.)
- ECOG performance status 0 to 3
- Written informed consent
- Absolute neutrophil count \> 1.5 x 10\^9/L.
- Absence of synchronic or non-synchronic neoplasia with the exception of non-melanoma skin tumors or in situ cervical carcinoma.
- CD4+ lymphocyte count \> 100/µL
Exclusion
- Patients with diffuse large B cell lymphoma previously treated.
- Patients with primary central nervous system lymphoma.
- Patients with Burkitt or Burkitt-like NHL.
- CD4+ lymphocyte count \< 100/µL
- Opportunistic infections or other AIDS-related neoplasias in activity.
- Active drug-addiction.
- Pregnant or lactating women or adults of fertile age who do not use an effective contraceptive method.
- Patients with serious altered renal function (creatinine \> 2.5 x upper limit of normal \[ULN\]) or hepatic \[bilirubin, ALT or AST \> 2.5 x ULN\], except if the investigators suspect that they are caused by the disease.
- Cardiac insufficiency with ejection fraction \< 40%
- Patients with serious psychiatric diseases that can interfere with their capacity to understand the study (including alcoholism or active drug-addiction).
- ECOG \> 3
- Patients with a known hypersensitivity to murine proteins or any other component of the study drugs.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00466258
Start Date
October 1 2006
End Date
November 1 2009
Last Update
November 25 2009
Active Locations (15)
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1
H. Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
2
Germans Trias i Pujol
Badalona, Barcelona, Spain
3
H. Clínic i Provincial, Barcelona
Barcelona, Barcelona, Spain
4
H. Vall d'Hebron, Barcelona
Barcelona, Barcelona, Spain