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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00429065 |
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Date of registration:
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30/01/2007 |
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Primary sponsor: |
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Public title:
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Treatment of Good Prognosis, BCL-6 Negative Diffuse Large Cell Lymphoma With CHOP-R in Patients < 61 Years Old.
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Scientific title:
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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. |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00429065 |
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Study type:
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Observational |
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Study design:
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Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal, Time Perspective: Prospective
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Silvia Rivas-Vera, MD |
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Address:
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Telephone:
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56 28 04 46 |
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Email:
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srivasv02@yahoo.com.mx |
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Affiliation:
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Name:
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Pedro Sobrevilla-Calvo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Cancerologia Mexico |
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Name:
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Silvia Rivas-Vera, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto Nacional de Cancerologia Mexico |
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Key inclusion & exclusion criteria
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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
Age minimum:
15 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Hodgkin Lymphoma
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Intervention(s)
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Drug: Rituximab
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Secondary ID(s)
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Hemato INCAN 01/2007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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