HIV InfectionsPhase 4LINFOTARGAMNCT00466258
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)
A Phase 4 study testing R-CHOP, Highly active antiretroviral therapy and Central nervous system (CNS) prophylaxis in people with HIV Infections and Diffuse Large B Cell Lymphoma, run by PETHEMA Foundation at 15 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections, Diffuse Large B Cell Lymphoma
- What is being tested?
- R-CHOP, Highly active antiretroviral therapy and Central nervous system (CNS) prophylaxis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 50 participants
- Where
- 15 sitesSpain
- Study dates
- Oct 2006to Nov 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Germans Trias i Pujol
Badalona, Barcelona
H. Clínic i Provincial, Barcelona
Barcelona, Barcelona
H. Vall d'Hebron, Barcelona
Barcelona, Barcelona
Hospital del Mar
Barcelona, Barcelona
Hospital Sant Pau, Barcelona
Barcelona, Barcelona
ICO - Duran i Reynals, Hospitalet de Llobregat
Barcelona, Barcelona
ICO - Josep Trueta
Girona, Girona
H. Gregorio Marañón
Madrid, Madrid
Consorci Sanitari de Mataró
Mataró, Barcelona
H. Son Llatzer
Palma de Mallorca, Balearic Islands
Hospital de Navarra
Pamplona, Navarre
H. Parc Taulí
Sabadell, Barcelona
H. Joan XXIII
Tarragona, Tarragona
Consorci Sanitari de Terrassa
Terrassa, Barcelona
Hospital Universitario Dr. Peset
Valencia, Valencia
About this study
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)
Main objective:
- To evaluate the applicability of the treatment:
Read more
- 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).
Read the detailed description
This is a clinical trial with a pharmaceutical drug used in the same conditions of authorization.
- Conditions
- HIV Infections, Diffuse Large B Cell Lymphoma
- Being tested
- R-CHOP, Highly active antiretroviral therapy, Central nervous system (CNS) prophylaxis, Prophylaxis of opportunistic infections and support treatment
- Keywords
- Diffuse large B cell lymphoma, HIV, R-CHOP, Highly active antiretroviral therapy, Treatment Experienced
- Medical subject headings
- HIV Infections, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-CHOPDrug
- 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 therapyDrug
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) prophylaxisDrug
methotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg)
Prophylaxis of opportunistic infections and support treatmentDrug
Pegfilgrastim
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI)
Measured: 6 months
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
Measured: 6 months
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)
Measured: 6 months
Secondary outcomes (7)
efficacy of the treatment in patients with DLBCL and HIV infection after 6 cycles of treatment with R-CHOP administered every 14 days
Measured: 1 year
global response and complete remission rate
Measured: 1 year
duration of the response
Measured: 5 years
event-free survival probability in 5 years
Measured: 5 years
global survival probability in 5 years
Measured: 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
Measured: 2 years
impact of the therapeutic combination of R-CHOP and HAART in the parameters of the HIV infection (HIV viral load and CD4+ lymphocyte count)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startOct 2006
- Primary completionMay 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PETHEMA Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Ribera Josep M, Dr, Principal investigator, Germans Trias i Pujol HospitalOriol Albert, Dr, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466258
- Sponsor's protocol ID
- 2006-003750-23
- Other IDs
- LINFOTARGAM
- Acronym
- LINFOTARGAM
- Status last verified
- Nov 2009
- First submitted
- 25 Apr 2007
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1093/jnci/dji085. No abstract available.
PubMed 15769998Noy A. Update in HIV-associated lymphoma. Curr Opin Oncol. 2004 Sep;16(5):450-4. doi: 10.1097/00001622-200409000-00007.
PubMed 15314514Bonnet F, Lewden C, May T, Heripret L, Jougla E, Bevilacqua S, Costagliola D, Salmon D, Chene 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. doi: 10.1002/cncr.20354.
PubMed 15241829Carrieri 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.
PubMed 12455069Ribera 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.
PubMed 15228895Hoffmann 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.
PubMed 15142115Navarro 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.
PubMed 15921395Spina 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. doi: 10.1086/380129. Epub 2003 Dec 5.
PubMed 14679461J 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
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. doi: 10.1200/JCO.2003.06.013.
PubMed 14581418Pantanowitz Lbeckwith B, Dezube BJ. HIV-associated plasma cell neoplasia. HIV AIDS Rev 2004; 3: 47-50.
Mate JL, Navarro JT, Ariza A, Ribera JM, Castella E, Junca J, Tural C, Nomdedeu JF, Bellosillo B, Serrano S, Granada I, Milla F, Feliu E. Oral solid form of primary effusion lymphoma mimicking plasmablastic lymphoma. Hum Pathol. 2004 May;35(5):632-5. doi: 10.1016/j.humpath.2003.11.005.
PubMed 15138941Navarro JT, Ribera JM, Junca J, Milla 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. doi: 10.1016/s0046-8177(03)00093-5. No abstract available.
PubMed 12827623Skiest 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. doi: 10.1097/00002030-200308150-00007.
PubMed 12891064JM 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00466258
- Acronym / sponsor ID
- LINFOTARGAM / 2006-003750-23
- Conditions
- HIV Infections, Diffuse Large B Cell Lymphoma
- Keywords
- Diffuse large B cell lymphoma, HIV, R-CHOP, Highly active antiretroviral therapy, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- PETHEMA FoundationUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 therapyCombined 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) prophylaxismethotrexate (12 mg) cytarabine (30 mg) hydrocortisone (20 mg) | Drug | – |
| Prophylaxis of opportunistic infections and support treatmentPegfilgrastim | Drug | – |
Primary outcome
treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI)
Time frame: 6 months
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
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
7 secondary outcomes
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
global response and complete remission rate
Time frame: 1 year
duration of the response
Time frame: 5 years
event-free survival probability in 5 years
Time frame: 5 years
global survival probability in 5 years
Time frame: 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
Time frame: 2 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
- Background: PubMed 15769998Engels 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. doi: 10.1093/jnci/dji085. No abstract available.
- Background: PubMed 15314514Noy A. Update in HIV-associated lymphoma. Curr Opin Oncol. 2004 Sep;16(5):450-4. doi: 10.1097/00001622-200409000-00007.
- Background: PubMed 15241829Bonnet F, Lewden C, May T, Heripret L, Jougla E, Bevilacqua S, Costagliola D, Salmon D, Chene 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. doi: 10.1002/cncr.20354.
- Background: PubMed 12455069Carrieri 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.
- Background: PubMed 15228895Ribera 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.
- Background: PubMed 15142115Hoffmann 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.
- Background: PubMed 15921395Navarro 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.
- Background: PubMed 14679461Spina 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. doi: 10.1086/380129. Epub 2003 Dec 5.
- BackgroundJ 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
- Background: PubMed 14581418Simonelli 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. doi: 10.1200/JCO.2003.06.013.
- BackgroundPantanowitz Lbeckwith B, Dezube BJ. HIV-associated plasma cell neoplasia. HIV AIDS Rev 2004; 3: 47-50.
- Background: PubMed 15138941Mate JL, Navarro JT, Ariza A, Ribera JM, Castella E, Junca J, Tural C, Nomdedeu JF, Bellosillo B, Serrano S, Granada I, Milla F, Feliu E. Oral solid form of primary effusion lymphoma mimicking plasmablastic lymphoma. Hum Pathol. 2004 May;35(5):632-5. doi: 10.1016/j.humpath.2003.11.005.
- Spanish Association of HaematologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ribera Josep M, Dr principal investigator
Germans Trias i Pujol Hospital
Oriol Albert, Dr principal investigator
Germans Trias i Pujol Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing R-CHOP, Highly active antiretroviral therapy and Central nervous system (CNS) prophylaxis in people with HIV Infections and Diffuse Large B Cell Lymphoma, run by PETHEMA Foundation at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00466258, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.