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 because the information has not been verified recently.
Verified January 2007 by Instituto Nacional de Cancerologia de Mexico.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier:
NCT00429065
First received: January 30, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  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
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

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 30, 2007
Last Updated: January 30, 2007
Health Authority: Mexico: Ethics Committee

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014