Treatment of Good Prognosis, BCL-6 Negative Diffuse Large Cell Lymphoma With CHOP-R in Patients < 61 Years Old.
- Conditions
- Non-Hodgkin Lymphoma
- Registration Number
- NCT00429065
- Lead Sponsor
- Instituto Nacional de Cancerologia de Mexico
- Brief Summary
The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- Stage I
- Previous treatment
- Lymphomatous central nervous system involvement
- Heart disease
- Kidney failure (serum creatinine > 2 mg/dl)
- HIV +
- Viral Hepatitis
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Instituto Nacional de Cancerologia
🇲🇽Mexico City, D.f., Mexico