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
Recruitment status was Recruiting
Sponsor:
Instituto Nacional de Cancerologia de Mexico
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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | January 30, 2007 | ||||||||
| Last Updated Date | January 30, 2007 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Treatment of Good Prognosis, BCL-6 Negative Diffuse Large Cell Lymphoma With CHOP-R in Patients < 61 Years Old. | ||||||||
| Official Title ICMJE | 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. | ||||||||
| Brief Summary | The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy. |
||||||||
| 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 ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Not Provided | ||||||||
| Study Population | Not Provided | ||||||||
| Condition ICMJE | Non-Hodgkin Lymphoma | ||||||||
| Intervention ICMJE | Drug: Rituximab | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 30 | ||||||||
| Completion Date | January 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 15 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Mexico | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00429065 | ||||||||
| Other Study ID Numbers ICMJE | Hemato INCAN 01/2007 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Instituto Nacional de Cancerologia de Mexico | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Instituto Nacional de Cancerologia de Mexico | ||||||||
| Verification Date | January 2007 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||