Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active 18 to 70 Other 2006-003750-23 LINFOTARGAM, NCT00466258

Trial Description

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 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).

Further Study Information

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

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Program for the Study and Treatment of Hematological Malignancies

Ribera Josep M, Dr

Principal Investigator

Oriol Albert, Dr

Principal Investigator

Ribera Josep M, Dr		Ph: 34 93 4978987
		Email: jribera@iconcologia.net

Spain
	Badalona
	Hospital Universitari Germans Trias i Pujol
	Barcelona
	Hospital Clinic de Barcelona
	Hospital de la Santa Cruz i Sant Pau
	Hospital Del Mar
	Institut Catala D'Oncologia
	Vall d'Hebron University Hospital
	Girona
	Hospital Universitari Josep Trueta de Girona
	Madrid
	Hospital General Universitario Gregorio Maranon
	Mataro
	Hospital de Mataro
	Palma de Mallorca
	Hospital Son Llatzer
	Pamplona
	Clinica Universitaria
	Sabadell
	Hospital de Sabadell
	Tarragona
	Hospital Universitari de Tarragona Joan XXIII
	Terrassa
	Hospital Consorci Sanitari De Terrassa
	Valencia
	Hospital Universitario Dr. Peset

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00466258
Information obtained from ClinicalTrials.gov on July 16, 2008