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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Treatment Active 15 to 60 Other Hemato INCAN 01/2007 NCT00429065

Trial Description

Summary

The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy.

Further Study Information

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

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Instituto Nacional de Cancerologia

Pedro Sobrevilla-Calvo, MD

Principal Investigator

Silvia Rivas-Vera, MD

Principal Investigator

Silvia Rivas-Vera, MD		Ph: 56 28 04 46
		Email: srivasv02@yahoo.com.mx

Pedro Sobrevilla-Calvo, MD		Ph: 56 28 04 16
		Email: sobrevilla.pedro@gmail.com

Mexico
	Mexico City
	Instituto Nacional de Cancerologia

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00429065
Information obtained from ClinicalTrials.gov on May 27, 2008