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Treatment of Good Prognosis, BCL-6 Negative Diffuse Large Cell Lymphoma With CHOP-R in Patients < 61 Years Old.

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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00429065
Enrollment
30
Registered
2007-01-31
Start date
2007-01-31
Completion date
2007-01-31
Last updated
2007-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin Lymphoma

Keywords

Non-Hodgkin lymphoma, rituximab, immunotherapy

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

Interventions

DRUGRituximab

Sponsors

Instituto Nacional de Cancerologia de Mexico
Lead SponsorOTHER

Study design

Observational model
DEFINED_POPULATION
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No

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

Countries

Mexico

Contacts

Primary ContactSilvia Rivas-Vera, MD
srivasv02@yahoo.com.mx56 28 04 46
Backup ContactPedro Sobrevilla-Calvo, MD
sobrevilla.pedro@gmail.com56 28 04 16

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026