ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00429065
Recruitment Status : Unknown
Verified January 2007 by Instituto Nacional de Cancerologia de Mexico.
Recruitment status was:  Recruiting
First Posted : January 31, 2007
Last Update Posted : January 31, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Non-Hodgkin Lymphoma Drug: Rituximab

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


Study Type : Observational
Enrollment : 30 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: 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.
Study Start Date : January 2007
Study Completion Date : January 2007






Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429065


Contacts
Contact: Silvia Rivas-Vera, MD 56 28 04 46 srivasv02@yahoo.com.mx
Contact: Pedro Sobrevilla-Calvo, MD 56 28 04 16 sobrevilla.pedro@gmail.com

Locations
Mexico
Instituto Nacional de Cancerologia Recruiting
Mexico City, D.f., Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
Principal Investigator: Pedro Sobrevilla-Calvo, MD Instituto Nacional de Cancerologia Mexico
Principal Investigator: Silvia Rivas-Vera, MD Instituto Nacional de Cancerologia Mexico

Publications:
ClinicalTrials.gov Identifier: NCT00429065     History of Changes
Other Study ID Numbers: Hemato INCAN 01/2007
First Posted: January 31, 2007    Key Record Dates
Last Update Posted: January 31, 2007
Last Verified: January 2007

Keywords provided by Instituto Nacional de Cancerologia de Mexico:
Non-Hodgkin lymphoma
rituximab
immunotherapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents