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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Instituto Nacional de Cancerologia de Mexico.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00429065
First Posted: January 31, 2007
Last Update Posted: January 31, 2007
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.
Information provided by:
Instituto Nacional de Cancerologia de Mexico
  Purpose
The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy.

Condition Intervention Phase
Non-Hodgkin Lymphoma Drug: Rituximab Phase 4

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Instituto Nacional de Cancerologia de Mexico:

Estimated Enrollment: 30
Study Start Date: January 2007
Estimated Study Completion Date: January 2007
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

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00429065     History of Changes
Other Study ID Numbers: Hemato INCAN 01/2007
First Submitted: January 30, 2007
First Posted: January 31, 2007
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


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