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)
NCT ID: NCT00466258
Last Updated: 2009-11-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-10-31
Study Completion Date
2009-11-30
Brief Summary
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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).
* 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).
Detailed Description
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This is a clinical trial with a pharmaceutical drug used in the same conditions of authorization.
Conditions
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HIV Infections
Diffuse Large B Cell Lymphoma
Keywords
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Diffuse large B cell lymphoma
HIV
R-CHOP
Highly active antiretroviral therapy
Treatment Experienced
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Interventions
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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.
Intervention Type
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.
Intervention Type
DRUG
Central nervous system (CNS) prophylaxis
methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)
Intervention Type
DRUG
Prophylaxis of opportunistic infections and support treatment
Pegfilgrastim
Intervention Type
DRUG
Eligibility Criteria
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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
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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PETHEMA Foundation
OTHER
Sponsor Role
lead
Responsible Party
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pethema
Principal Investigators
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Ribera Josep M, Dr
Role: PRINCIPAL_INVESTIGATOR
Germans Trias i Pujol Hospital
Oriol Albert, Dr
Role: PRINCIPAL_INVESTIGATOR
Germans Trias i Pujol Hospital
Locations
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H. Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Site Status
Germans Trias i Pujol
Badalona, Barcelona, Spain
Site Status
H. Clínic i Provincial, Barcelona
Barcelona, Barcelona, Spain
Site Status
H. Vall d'Hebron, Barcelona
Barcelona, Barcelona, Spain
Site Status
Hospital del Mar
Barcelona, Barcelona, Spain
Site Status
Hospital Sant Pau, Barcelona
Barcelona, Barcelona, Spain
Site Status
ICO - Duran i Reynals, Hospitalet de Llobregat
Barcelona, Barcelona, Spain
Site Status
Consorci Sanitari de Mataró
Mataró, Barcelona, Spain
Site Status
H. Parc Taulí
Sabadell, Barcelona, Spain
Site Status
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Site Status
ICO - Josep Trueta
Girona, Girona, Spain
Site Status
H. Gregorio Marañón
Madrid, Madrid, Spain
Site Status
Hospital de Navarra
Pamplona, Navarre, Spain
Site Status
H. Joan XXIII
Tarragona, Tarragona, Spain
Site Status
Hospital Universitario Dr. Peset
Valencia, Valencia, Spain
Site Status
Countries
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Spain
References
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Oriol A, Ribera JM, Esteve J, Sanz MA, Brunet S, Garcia-Boyero R, Fernandez-Abellan P, Marti JM, Abella E, Sanchez-Delgado M, Penarrubia MJ, Besalduch J, Moreno MJ, Borrego D, Feliu E, Ortega JJ; PETHEMA Group, Spanish Society of Hematology. Lack of influence of human immunodeficiency virus infection status in the response to therapy and survival of adult patients with mature B-cell lymphoma or leukemia. Results of the PETHEMA-LAL3/97 study. Haematologica. 2003 Apr;88(4):445-53.
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Carrieri MP, Pradier C, Piselli P, Piche M, Rosenthal E, Heudier P, Durant J, Serraino D. Reduced incidence of Kaposi's sarcoma and of systemic non-hodgkin's lymphoma in HIV-infected individuals treated with highly active antiretroviral therapy. Int J Cancer. 2003 Jan 1;103(1):142-4. doi: 10.1002/ijc.10790. No abstract available.
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BACKGROUND
Ribera JM, Navarro JT. [Lymphomas in patients with HIV infection. A change for the better]. Enferm Infecc Microbiol Clin. 2004 Jun-Jul;22(6):313-4. doi: 10.1157/13063040. No abstract available. Spanish.
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BACKGROUND
Hoffmann C, Chow KU, Wolf E, Faetkenheuer G, Stellbrink HJ, van Lunzen J, Jaeger H, Stoehr A, Plettenberg A, Wasmuth JC, Rockstroh J, Mosthaf F, Horst HA, Brodt HR. Strong impact of highly active antiretroviral therapy on survival in patients with human immunodeficiency virus-associated Hodgkin's disease. Br J Haematol. 2004 May;125(4):455-62. doi: 10.1111/j.1365-2141.2004.04934.x.
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Navarro JT, Lloveras N, Ribera JM, Oriol A, Mate JL, Feliu E. The prognosis of HIV-infected patients with diffuse large B-cell lymphoma treated with chemotherapy and highly active antiretroviral therapy is similar to that of HIV-negative patients receiving chemotherapy. Haematologica. 2005 May;90(5):704-6.
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J Berenguer, R Rubio, JM Ribera, A Antela, J Santos, P Miralles, et al. 10Th Congress of Retroviruses and Opportunistic infections. 2003. Characteristics and outcome of AIDS-related non-Hodgkin's lymphoma before and alter the introduction of HAART (GESIDA 23/01). Abstract 802
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Related Links
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http://www.aehh.org
Spanish Association of Haematology
Other Identifiers
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LINFOTARGAM
Identifier Type: -
Identifier Source: secondary_id
2006-003750-23
Identifier Type: -
Identifier Source: org_study_id