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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)


Phase 4
18 Years
70 Years
Not Enrolling
Both
HIV Infections, Diffuse Large B Cell Lymphoma

Thank you

Trial Information

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)


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

treatment toxicity according to the CTC criteria (version 3.0) of the National Cancer Institute (NCI)

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Ribera Josep M, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

HOSPITAL GERMANS TRIAS I PUJOL

Authority:

Spain: Ministry of Health

Study ID:

2006-003750-23

NCT ID:

NCT00466258

Start Date:

October 2006

Completion Date:

November 2009

Related Keywords:

  • HIV Infections
  • Diffuse Large B Cell Lymphoma
  • Diffuse large B cell lymphoma
  • HIV
  • R-CHOP
  • Highly active antiretroviral therapy
  • Treatment Experienced
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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