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)

This study has been completed.
Sponsor:
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00466258
First received: April 25, 2007
Last updated: November 23, 2009
Last verified: November 2009

April 25, 2007
November 23, 2009
October 2006
May 2009   (final data collection date for primary outcome measure)
  • treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the treatment toxicity according to the CTC criteria (version 3.0) of
  • Opportunistic and no opportunistic infections tax after 6 cycles of treatment
  • considering the delays in the administration of the cycles and the reductions in
  • the National Cancer Institute (NCI).
  • with R-CHOP administrated every 14 days, HAART-associated in patients with
  • DLBCL and HIV infection.
  • To evaluate the adherence to the treatment with 6 cycles of R-CHOP
  • the doses of chemotherapy (planed dose administrated in predicted term)
Complete list of historical versions of study NCT00466258 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • global response and complete remission rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • duration of the response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • event-free survival probability in 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • global survival probability in 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of the treatment in patients with DLBCL and HIV infection
  • after 6 cycles of treatment with R-CHOP administrated every 14 days:
  • To determinate the global response and complete remission tax.
  • To evaluate the duration of the response.
  • To evaluate the event-free survival probability in 5 years.
  • To evaluate the global survival probability in 5 years.
  • To identify the predictors factors of the response after 6 cycles of treatment with RCHOP
  • administrated every 14 days in patients with DLBCL and HIV infection.
  • To evaluate the impact of the therapeutic combination with R-CHOP and HAART in
  • the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count).
Not Provided
Not Provided
 
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)

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Diffuse Large B Cell Lymphoma
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
November 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00466258
2006-003750-23, LINFOTARGAM
Yes
Pethema, pethema
PETHEMA Foundation
Not Provided
Principal Investigator: Ribera Josep M, Dr HOSPITAL GERMANS TRIAS I PUJOL
Principal Investigator: Oriol Albert, Dr HOSPITAL GERMANS TRIAS I PUJOL
PETHEMA Foundation
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP