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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-11-25

No results posted yet for this study

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).

Conditions

Interventions

DRUG

R-CHOP

* 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.

DRUG

Highly active antiretroviral therapy

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

DRUG

Central nervous system (CNS) prophylaxis

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

DRUG

Prophylaxis of opportunistic infections and support treatment

Pegfilgrastim

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Ribera Josep M, Dr · Germans Trias i Pujol Hospital

  • Oriol Albert, Dr · Germans Trias i Pujol Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-05-31
Completion
2009-11-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00466258 on ClinicalTrials.gov