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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) (LINFOTARGAM)

Primary Purpose

HIV Infections, Diffuse Large B Cell Lymphoma

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
R-CHOP
Highly active antiretroviral therapy
Central nervous system (CNS) prophylaxis
Prophylaxis of opportunistic infections and support treatment
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Diffuse large B cell lymphoma, HIV, R-CHOP, Highly active antiretroviral therapy, Treatment Experienced

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • H. Son Llatzer
  • Germans Trias i Pujol
  • Consorci Sanitari de Mataró
  • H. Parc Taulí
  • Consorci Sanitari de Terrassa
  • Hospital de Navarra
  • H. Clínic i Provincial, Barcelona
  • H. Vall d'Hebron, Barcelona
  • Hospital del Mar
  • Hospital Sant Pau, Barcelona
  • ICO - Duran i Reynals, Hospitalet de Llobregat
  • ICO - Josep Trueta
  • H. Gregorio Marañón
  • H. Joan XXIII
  • Hospital Universitario Dr. Peset

Outcomes

Primary Outcome Measures

treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI)
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
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 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
global response and complete remission rate
duration of the response
event-free survival probability in 5 years
global survival probability in 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
impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count)

Full Information

First Posted
April 25, 2007
Last Updated
November 23, 2009
Sponsor
PETHEMA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00466258
Brief Title
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)
Acronym
LINFOTARGAM
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
PETHEMA Foundation

4. Oversight

Data Monitoring Committee
Yes

5. 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).
Detailed Description
This is a clinical trial with a pharmaceutical drug used in the same conditions of authorization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Diffuse Large B Cell Lymphoma
Keywords
Diffuse large B cell lymphoma, HIV, R-CHOP, Highly active antiretroviral therapy, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
R-CHOP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Highly active antiretroviral therapy
Intervention Description
Combined antiretroviral treatment (TARGA) wich include at lest 3 drugs. The combination should be accepted as an initial or rescue treatment.
Intervention Type
Drug
Intervention Name(s)
Central nervous system (CNS) prophylaxis
Intervention Description
methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)
Intervention Type
Drug
Intervention Name(s)
Prophylaxis of opportunistic infections and support treatment
Intervention Description
Pegfilgrastim
Primary Outcome Measure Information:
Title
treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI)
Time Frame
6 months
Title
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
Title
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 Outcome Measure Information:
Title
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
Title
global response and complete remission rate
Time Frame
1 year
Title
duration of the response
Time Frame
5 years
Title
event-free survival probability in 5 years
Time Frame
5 years
Title
global survival probability in 5 years
Time Frame
5 years
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ribera Josep M, Dr
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oriol Albert, Dr
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Son Llatzer
City
Palma de Mallorca
State/Province
Baleares
Country
Spain
Facility Name
Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Consorci Sanitari de Mataró
City
Mataro
State/Province
Barcelona
Country
Spain
Facility Name
H. Parc Taulí
City
Sabadell
State/Province
Barcelona
Country
Spain
Facility Name
Consorci Sanitari de Terrassa
City
Terrassa
State/Province
Barcelona
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
State/Province
Navarra
Country
Spain
Facility Name
H. Clínic i Provincial, Barcelona
City
Barcelona
Country
Spain
Facility Name
H. Vall d'Hebron, Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Sant Pau, Barcelona
City
Barcelona
Country
Spain
Facility Name
ICO - Duran i Reynals, Hospitalet de Llobregat
City
Barcelona
Country
Spain
Facility Name
ICO - Josep Trueta
City
Girona
Country
Spain
Facility Name
H. Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
H. Joan XXIII
City
Tarragona
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
Country
Spain

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Links:
URL
http://www.aehh.org
Description
Spanish Association of Haematology

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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)

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