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 (Other)

Overall Status

Completed

CT.gov ID

NCT00466258

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Main objective:

To evaluate the applicability of the treatment:

To evaluate the treatment toxicity according to the Common Terminology Criteria (CTC) version 3.0 of the National Cancer Institute (NCI).
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.
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):

To determine the global response and complete remission tax.
To evaluate the duration of the response.
To evaluate the probability of event-free survival in 5 years.
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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Diffuse Large B Cell Lymphoma	Drug: R-CHOP Drug: Highly active antiretroviral therapy Drug: Central nervous system (CNS) prophylaxis Drug: Prophylaxis of opportunistic infections and support treatment	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Outcome Measures

Primary Outcome Measures

treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI) [6 months]
opportunistic and non-opportunistic infections rate after 6 cycles of treatment with R-CHOP administered every 14 days and HAART in patients with DLBCL and HIV infection [6 months]
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) [6 months]

Secondary Outcome Measures

efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days [1 year]
global response and complete remission rate [1 year]
duration of the response [5 years]
event-free survival probability in 5 years [5 years]
global survival probability in 5 years [5 years]
predictive factors of the response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection [2 years]
impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	H. Son Llatzer	Palma de Mallorca	Baleares	Spain
2	Germans Trias i Pujol	Badalona	Barcelona	Spain
3	Consorci Sanitari de Mataró	Mataro	Barcelona	Spain
4	H. Parc Taulí	Sabadell	Barcelona	Spain
5	Consorci Sanitari de Terrassa	Terrassa	Barcelona	Spain
6	Hospital de Navarra	Pamplona	Navarra	Spain
7	H. Clínic i Provincial, Barcelona	Barcelona		Spain
8	H. Vall d'Hebron, Barcelona	Barcelona		Spain
9	Hospital del Mar	Barcelona		Spain
10	Hospital Sant Pau, Barcelona	Barcelona		Spain
11	ICO - Duran i Reynals, Hospitalet de Llobregat	Barcelona		Spain
12	ICO - Josep Trueta	Girona		Spain
13	H. Gregorio Marañón	Madrid		Spain
14	H. Joan XXIII	Tarragona		Spain
15	Hospital Universitario Dr. Peset	Valencia		Spain