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

Phase 1

Completed

• Conditions: Lymphoma; Non Hodgkin's Lymphoma

• Registration Number: NCT01527422
• Lead Sponsor: Fernando Cabanillas

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

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 250 mcg. When that dose is reached, if possible, the dose of Neulasta will be increased stepwise. CHOP-R will be delivered every 14 days at a fixed standard dose with dose adjustments of PEG-Filgrastim and GM-CSF upwards and downwards according to nadir or zenith blood counts.

1.2 Secondary Objective:

2. To generate preliminary pilot data as to the effectiveness of the regimen in inducing very early remissions as measured by the CT-PET scan technique.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2010-11
• Study Completion: 2011-03
• Status Verified: 2012-02
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-03
• Last Update Submitted: 2012-02-03
• Study First Posted: 2012-02-07
• Last Update Posted: 2012-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R	up to 3 years

Trial Locations

Locations (1)

Hospital Auxilio Mutuo Cancer Center; 🇵🇷 San Juan, Puerto Rico