Infections

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lymphoma

Communicable Diseases

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HIV Infections

Immunologic Deficiency Syndromes

Lymphoma, Large B-Cell, Diffuse

Virus Diseases

Lymphoma, B-Cell

Syndrome

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Disease Attributes

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Sexually Transmitted Diseases, Viral

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RNA Virus Infections

Genital Diseases

Urogenital Diseases

Lymphoma, Non-Hodgkin

Slow Virus Diseases

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B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Anti-Inflammatory Agents

All Drugs and Chemicals

Anti-Infective Agents

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Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cytarabine

Cyclophosphamide

Methotrexate

Prednisone

Rituximab

Vincristine

Anti-Retroviral Agents

Antiviral Agents

* Cyclophosphamide 750 mg/m2 i.v. day 1
* Adriamycin 50 mg/m2 i.v. day 1
* Vincristine 1,4 mg/m2 i.v. day 1
* Prednisone 100 mg i.v or oral. days 1-5.

R-CHOP

Combined antiretroviral treatment (TARGA) wich include at lest 3 drugs. The combination should be accepted as an initial or rescue treatment.

Highly active antiretroviral therapy

methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)

Central nervous system (CNS) prophylaxis

Prophylaxis of opportunistic infections and support treatment

Ribera Josep M, Dr

Oriol Albert, Dr

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 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-CHOP/14):

  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).

This is a clinical trial with a pharmaceutical drug used in the same conditions of authorization.

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)

LINFOTARGAM: First-line Treatment With Dose-dense Chemotherapy Plus Rituximab (R-CHOP/14) and Highly Active Antiretroviral Therapy (HAART) in Patients With Diffuse Large B Cell Lymphoma (DLBCL) and Infection With the Human Immunodeficiency Virus (HIV)

PETHEMA Foundation

Pethema

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)	NCT00466258	HIV Infections Diffuse Large B...	R-CHOP Highly active a... Central nervous... Prophylaxis of ...	18 Years - 70 Years	PETHEMA Foundation
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)	NCT00466258	HIV Infections Diffuse Large B...	R-CHOP Highly active a... Central nervous... Prophylaxis of ...	18 Years - 70 Years	PETHEMA Foundation

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