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NCT Number: NCT00466258

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)

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Diffuse Large B Cell Lymphoma Genital Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Lentivirus Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

H. Son Llatzer, Palma de Mallorca, Balearic Islands, Spain

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

R-CHOP

Drug
  • 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.

Highly active antiretroviral therapy

Drug

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

Central nervous system (CNS) prophylaxis

Drug

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

Prophylaxis of opportunistic infections and support treatment

Drug

Pegfilgrastim

Primary outcomes

  1. treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI)

    Time frame: 6 months

  2. 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

    Time frame: 6 months

  3. 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)

    Time frame: 6 months

Secondary outcomes

  1. efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days

    Time frame: 1 year

  2. global response and complete remission rate

    Time frame: 1 year

  3. duration of the response

    Time frame: 5 years

  4. event-free survival probability in 5 years

    Time frame: 5 years

  5. global survival probability in 5 years

    Time frame: 5 years

  6. predictive factors of the response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection

    Time frame: 2 years

  7. impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count)

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

PETHEMA Foundation

Other

Registry information

Official study 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)

Acronym: LINFOTARGAM

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 27, 2007
Registry last updated
Nov 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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