Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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 every 2 weeks with the practical advantage of requiring only one dose of PEG-filgrastim instead of daily doses of G-CSF.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fernando Cabanillas
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Cyclophosphamide; Doxorubicin; Lenograstim; Liposomal doxorubicin; Prednisone; Rituximab; Sargramostim; Vincristine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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