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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00466258
Other study ID # 2006-003750-23
Secondary ID LINFOTARGAM
Status Completed
Phase Phase 4
First received April 25, 2007
Last updated November 23, 2009
Start date October 2006
Est. completion date November 2009

Study information

Verified date November 2009
Source PETHEMA Foundation
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Interventional

Clinical Trial Summary

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).


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.
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.
Central nervous system (CNS) prophylaxis
methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)
Prophylaxis of opportunistic infections and support treatment
Pegfilgrastim

Locations

Country Name City State
Spain Germans Trias i Pujol Badalona Barcelona
Spain H. Clínic i Provincial, Barcelona Barcelona
Spain H. Vall d'Hebron, Barcelona Barcelona
Spain Hospital del Mar 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 Consorci Sanitari de Mataró Mataro Barcelona
Spain H. Son Llatzer Palma de Mallorca Baleares
Spain Hospital de Navarra Pamplona Navarra
Spain H. Parc Taulí Sabadell Barcelona
Spain H. Joan XXIII Tarragona
Spain Consorci Sanitari de Terrassa Terrassa Barcelona
Spain Hospital Universitario Dr. Peset Valencia

Sponsors (1)

Lead Sponsor Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (30)

Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer. Eur J Cancer. 2004 Oct;40(15):2201-16. Review. — View Citation

Bonnet F, Lewden C, May T, Heripret L, Jougla E, Bevilacqua S, Costagliola D, Salmon D, Chêne G, Morlat P. Malignancy-related causes of death in human immunodeficiency virus-infected patients in the era of highly active antiretroviral therapy. Cancer. 2004 Jul 15;101(2):317-24. — View Citation

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.

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. — View Citation

Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. — View Citation

Engels EA, Goedert JJ. Human immunodeficiency virus/acquired immunodeficiency syndrome and cancer: past, present, and future. J Natl Cancer Inst. 2005 Mar 16;97(6):407-9. — View Citation

Grigg A, Solal-Celigny P, Hoskin P, Taylor K, McMillan A, Forstpointner R, Bacon P, Renwick J, Hiddemann W; International Study Group. Open-label, randomized study of pegfilgrastim vs. daily filgrastim as an adjunct to chemotherapy in elderly patients with non-Hodgkin's lymphoma. Leuk Lymphoma. 2003 Sep;44(9):1503-8. — View Citation

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. — View Citation

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.

Juweid ME, Wiseman GA, Vose JM, Ritchie JM, Menda Y, Wooldridge JE, Mottaghy FM, Rohren EM, Blumstein NM, Stolpen A, Link BK, Reske SN, Graham MM, Cheson BD. Response assessment of aggressive non-Hodgkin's lymphoma by integrated International Workshop Criteria and fluorine-18-fluorodeoxyglucose positron emission tomography. J Clin Oncol. 2005 Jul 20;23(21):4652-61. Epub 2005 Apr 18. — View Citation

Kaplan LD, Lee JY, Ambinder RF, Sparano JA, Cesarman E, Chadburn A, Levine AM, Scadden DT. Rituximab does not improve clinical outcome in a randomized phase 3 trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin lymphoma: AIDS-Malignancies Consortium Trial 010. Blood. 2005 Sep 1;106(5):1538-43. Epub 2005 May 24. — View Citation

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).

Mate JL, Navarro JT, Ariza A, Ribera JM, Castellà E, Juncà J, Tural C, Nomdedeu JF, Bellosillo B, Serrano S, Granada I, Millá F, Feliu E. Oral solid form of primary effusion lymphoma mimicking plasmablastic lymphoma. Hum Pathol. 2004 May;35(5):632-5. — View Citation

Miralles P, Rubio C, Berenguer J, Ribera JM, Calvo F, Diaz Mediavilla J, Diez-Martín JL, López Aldeguer J, Valencia E, Rubio R. [GESIDA/PETHEMA guidelines for the diagnosis and treatment of lymphomas in HIV-infected patients]. Med Clin (Barc). 2002 Feb 23;118(6):225-36. Review. Spanish. Erratum in: Med Clin (Barc). 2002 Apr 27;118(15):582. Felipe C [corrected to Calvo F]. — View Citation

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. — View Citation

Navarro JT, Ribera JM, Juncà J, Millá F. Anorectal lymphoma without effusion associated with human herpesvirus-8 and type 1 Epstein-Barr virus in an HIV-infected patient. Hum Pathol. 2003 Jun;34(6):630. — View Citation

Noy A. Update in HIV-associated lymphoma. Curr Opin Oncol. 2004 Sep;16(5):450-4. Review. — View Citation

Oriol A, Ribera JM, Brunet S, del Potro E, Abella E, Esteve J. Highly active antiretroviral therapy and outcome of AIDS-related Burkitt's lymphoma or leukemia. Results of the PETHEMA-LAL3/97 study. Haematologica. 2005 Jul;90(7):990-2. — View Citation

Oriol A, Ribera JM, Esteve J, Sanz MA, Brunet S, Garcia-Boyero R, Fernández-Abellán P, Martí JM, Abella E, Sánchez-Delgado M, Peñarrubia 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. — View Citation

Pantanowitz Lbeckwith B, Dezube BJ. HIV-associated plasma cell neoplasia. HIV AIDS Rev 2004; 3: 47-50.

Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rübe C, Rudolph C, Reiser M, Hossfeld DK, Eimermacher H, Hasenclever D, Schmitz N, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of elderly patients with aggressive lymphomas: results of the NHL-B2 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):634-41. Epub 2004 Mar 11. — View Citation

Pfreundschuh M, Trümper L, Kloess M, Schmits R, Feller AC, Rudolph C, Reiser M, Hossfeld DK, Metzner B, Hasenclever D, Schmitz N, Glass B, Rübe C, Loeffler M; German High-Grade Non-Hodgkin's Lymphoma Study Group. Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood. 2004 Aug 1;104(3):626-33. Epub 2004 Feb 24. — View Citation

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. Spanish. — View Citation

Simonelli C, Spina M, Cinelli R, Talamini R, Tedeschi R, Gloghini A, Vaccher E, Carbone A, Tirelli U. Clinical features and outcome of primary effusion lymphoma in HIV-infected patients: a single-institution study. J Clin Oncol. 2003 Nov 1;21(21):3948-54. — View Citation

Skiest DJ, Crosby C. Survival is prolonged by highly active antiretroviral therapy in AIDS patients with primary central nervous system lymphoma. AIDS. 2003 Aug 15;17(12):1787-93. — View Citation

Spina M, Carbone A, Vaccher E, Gloghini A, Talamini R, Cinelli R, Martellotta F, Tirelli U. Outcome in patients with non-hodgkin lymphoma and with or without human immunodeficiency virus infection. Clin Infect Dis. 2004 Jan 1;38(1):142-4. Epub 2003 Dec 5. — View Citation

Spina M, Jaeger U, Sparano JA, Talamini R, Simonelli C, Michieli M, Rossi G, Nigra E, Berretta M, Cattaneo C, Rieger AC, Vaccher E, Tirelli U. Rituximab plus infusional cyclophosphamide, doxorubicin, and etoposide in HIV-associated non-Hodgkin lymphoma: pooled results from 3 phase 2 trials. Blood. 2005 Mar 1;105(5):1891-7. Epub 2004 Nov 18. — View Citation

Tanosaki R, Okamoto S, Akatsuka N, Ishida A, Michikawa N, Masuda Y, Uchida H, Murata M, Kizaki M, Ikeda Y. Dose escalation of biweekly cyclophosphamide, doxorubicin, vincristine, and prednisolone using recombinant human granulocyte colony stimulating factor in non-Hodgkin's lymphoma. Cancer. 1994 Oct 1;74(7):1939-44. — View Citation

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.

* Note: There are 30 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI) 6 months Yes
Primary 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 6 months Yes
Primary 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) 6 months No
Secondary efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days 1 year No
Secondary global response and complete remission rate 1 year No
Secondary duration of the response 5 years No
Secondary event-free survival probability in 5 years 5 years No
Secondary global survival probability in 5 years 5 years No
Secondary predictive factors of the response after 6 cycles of treatment with R-CHOP administered every 14 days in patients with DLBCL and HIV infection 2 years No
Secondary impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count) 1 year No
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