Status:
COMPLETED
Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL
Lead Sponsor:
Fernando Cabanillas
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Lymphoma
Non Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
We now propose to investigate the combination of CHOP-Rituxan plus PEG-Filgrastim (PEG-filgrastim) and GM-CSF. PEG-Filgrastim would be given in order to allow us to administer the chemotherapy courses...
Detailed Description
1.1 Primary Objective: 1. To identify the ideal dose of the combination of CHOP-R with PEG-Filgrastim (Neulasta) using first a fixed dose of Neulasta and an escalating dose of GM-CSF (Leukine) up to ...
Eligibility Criteria
Inclusion
- Patients with previously untreated aggressive non-Hodgkin's Lymphoma. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas.
- Must have measurable or evaluable disease.
- Stage I-IV patients are eligible
- Patients must be 18 years or older.
- No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria)
- Written Consent
Exclusion
- HIV positive patients and those with Hepatitis B or C will be excluded from this protocol.
- Patients with inadequate bone marrow and organ function as defined below:
- Neutrophils \<1,000/l
- Platelets \<100,000/l
- Billirubin \>2
- Creatinine \>2.0 or estimated CrCl \<30 cc/min
- CNS involvement by Lymphoma.
- Uncontrolled intercurrent disease including arrhythmias, angina pectoris, Class III-IV Congestive heart failure (CHF symptoms on less than ordinary exertion or at rest) or active infection.
- Active infection or fever \> 38.2 degrees C unless due to lymphoma.
- Subject is not using adequate contraceptive precautions.
- Pregnancy or breast feeding
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01527422
Start Date
January 1 2006
End Date
March 1 2011
Last Update
February 7 2012
Active Locations (1)
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1
Hospital Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, Puerto Rico, 00919