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Selection of Young Patients (< 61 Years), With Good Prognosis Diffuse Large B Cell Lymphoma, According to the Immunophenotype (BCL-6 Negative) to be Treated With Chemoimmunotherapy, With R-CHOP. A Pilot Study.


Phase 4
15 Years
60 Years
Open (Enrolling)
Both
Non-Hodgkin Lymphoma

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Trial Information

Selection of Young Patients (< 61 Years), With Good Prognosis Diffuse Large B Cell Lymphoma, According to the Immunophenotype (BCL-6 Negative) to be Treated With Chemoimmunotherapy, With R-CHOP. A Pilot Study.


Treatment with rituximab and chemotherapy (R-CHOP)is the accepted treatment for young
patients with diffuse large B cell Non-Hodgkin's Lymphoma. However not every patient
benefits with this expensive therapy. Recent data suggest that patients with BCL-6 negative
lymphoma are more sensitive to Rituximab therapy. It is also known that patients with
high-intermediate and high IPI risk does not benefit form standard three weekly CHOP
chemotherapy.

In this study we intend to define a subgroup of patients in whom this therapy will be of
maximum benefit.

We will prospectively treat a group of patients with the following characteristics:

< 60 years old low and low intermediate IPI risk BCL-6 negative B-cell NHL Treatment
regimen: R-CHOP (standard dosis) for 8 cycles


Inclusion Criteria:



- Diagnosis of Large B cell Non-Hodgkin Lymphoma CD20+

- BCL-6 negative

- Age < 61 years old

- ECOG 2 or less

- IPI low, low intermediate

- Stage II, III or IV

- Signed Informed Consent

Exclusion Criteria:

- Stage I

- Previous treatment

- Lymphomatous central nervous system involvement

- Heart disease

- Kidney failure (serum creatinine > 2 mg/dl)

- HIV +

- Viral Hepatitis

- Pregnancy

Type of Study:

Observational

Study Design:

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Pedro Sobrevilla-Calvo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto Nacional de Cancerologia Mexico

Authority:

Mexico: Ethics Committee

Study ID:

Hemato INCAN 01/2007

NCT ID:

NCT00429065

Start Date:

January 2007

Completion Date:

January 2007

Related Keywords:

  • Non-Hodgkin Lymphoma
  • Non-Hodgkin lymphoma
  • rituximab
  • immunotherapy
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin

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