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:
PETHEMA Foundation
Information provided by:
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT00466258
First received: April 25, 2007
Last updated: November 23, 2009
Last verified: November 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Diffuse Large B Cell Lymphoma |
Drug: R-CHOP Drug: Highly active antiretroviral therapy Drug: Central nervous system (CNS) prophylaxis Drug: Prophylaxis of opportunistic infections and support treatment |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Rituximab
U.S. FDA Resources
Further study details as provided by PETHEMA Foundation:
Primary Outcome Measures:
- 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 ]
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 [ 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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
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
This is a clinical trial with a pharmaceutical drug used in the same conditions of authorization.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466258
Locations
| Spain | |
| H. Son Llatzer | |
| Palma de Mallorca, Baleares, Spain | |
| Germans Trias i Pujol | |
| Badalona, Barcelona, Spain | |
| Consorci Sanitari de Mataró | |
| Mataro, Barcelona, Spain | |
| H. Parc Taulí | |
| Sabadell, Barcelona, Spain | |
| Consorci Sanitari de Terrassa | |
| Terrassa, Barcelona, Spain | |
| Hospital de Navarra | |
| Pamplona, Navarra, Spain | |
| Hospital del Mar | |
| Barcelona, Spain | |
| H. Clínic i Provincial, Barcelona | |
| Barcelona, Spain | |
| H. Vall d'Hebron, Barcelona | |
| Barcelona, Spain | |
| Hospital Sant Pau, Barcelona | |
| Barcelona, Spain | |
| ICO - Duran i Reynals, Hospitalet de Llobregat | |
| Barcelona, Spain | |
| ICO - Josep Trueta | |
| Girona, Spain | |
| H. Gregorio Marañón | |
| Madrid, Spain | |
| H. Joan XXIII | |
| Tarragona, Spain | |
| Hospital Universitario Dr. Peset | |
| Valencia, Spain | |
Sponsors and Collaborators
PETHEMA Foundation
Investigators
| Principal Investigator: | Ribera Josep M, Dr | HOSPITAL GERMANS TRIAS I PUJOL |
| Principal Investigator: | Oriol Albert, Dr | HOSPITAL GERMANS TRIAS I PUJOL |
More Information
Additional Information:
Publications:
JM Ribera, JT Navarro. Linfomas en pacientes con infección por el VIH. Las cosas han cambiado para bien. Enf Infecc Microbiol Clin 2004; 22: 313-314.
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
JM Ribera, A Oriol, M Morgades, E Gonzalez-Barca, A López-Guillermo, A López, et al. Treatment with rituximab, CHOP and highly active antiretroviral therapy (HAART) in AIDS-related diffuse large B-cell lymphomas (DLBCL). Study of 60 patients. American Society of Hematology. 47th Annual Meeting. Atlanta, December 10-13, 2005. Abstract 774. Blood 2005, 106 (11): 228a.
Lopez A, Fernandez de Sevilla, A, Castaigne S, Greil R, Sierra J, Sanchez J, et al. Pegfigrastim supports delivery of CHOP-R chemotherapy administered every 14 days: a randomised phase II study. Blood 2004; 104: 904a-905a (abstract 3311).
Boue F, Gabarre J, Gisselbrecht Ch, Reynes J, Plantier I, Morlat P, et al. CHOP chemotherapy plus rituximab in HIV patients with high-grade lymphoma. Results of an ANRS trial. 44th Annual Meeting of the American Society of Hematology 2002. Blood 2002; 100 (suppl): 470a.
Thomas DA, Cortes J, Giles FJ, Faderl S, O'Brien S, Garcia-Manero G, et al. Rituximab and hyper-CVAD for adult Burkitt's or Burkitt-like leukemia or lymphoma. 44th Annual Meeting of the American Society of Hematology 2002. Blood 2002; 100 Suppl 763a.
| Responsible Party: | Pethema, pethema |
| ClinicalTrials.gov Identifier: | NCT00466258 History of Changes |
| Other Study ID Numbers: | 2006-003750-23, LINFOTARGAM |
| Study First Received: | April 25, 2007 |
| Last Updated: | November 23, 2009 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by PETHEMA Foundation:
|
Diffuse large B cell lymphoma HIV R-CHOP Highly active antiretroviral therapy Treatment Experienced |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013