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

January 30, 2007
January 30, 2007
January 2007
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No Changes Posted
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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.

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

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

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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Non-Hodgkin Lymphoma
Drug: Rituximab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2007
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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
Both
15 Years to 60 Years
No
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
Mexico
 
NCT00429065
Hemato INCAN 01/2007
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Instituto Nacional de Cancerologia de Mexico
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Principal Investigator: Pedro Sobrevilla-Calvo, MD Instituto Nacional de Cancerologia Mexico
Principal Investigator: Silvia Rivas-Vera, MD Instituto Nacional de Cancerologia Mexico
Instituto Nacional de Cancerologia de Mexico
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP