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

NCT ID: NCT01527422

Last Updated: 2012-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2011-03-31

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.

Conditions

Lymphoma; Non Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

Rituximab will be administered on day 1 of courses 1-6 at 375 mg/m2 concurrently with CHOP-R.All patients will receive antiemetics priorchemotherapy.Courses will be repeated every 14 days.If blood counts don't allow re-treatment on day 14 the counts will be repeated at least twice per week until recovery allows re-treatment.The aim is to achieve a dose that will be as close as possible to 250 mcg and that will result in grade 0 or grade 1A or 1B toxicity at the most. The dose of PEG-Filgrastim will initially be fixed at 3 mg until dose level +3 is reached (which includes 250 mcg Leukine) at which time the dose of Neulasta will be escalated if necessary. All patients will receive Neulasta as a subcutaneous injection on the day 3.

Intervention Type: DRUG

Other Intervention Names

Cyclophosphamide (Cytoxan); Doxorubicin (Adryamicin); Vincristine (Oncovin); Prednisone; Rituximab (Rituxan); Peg Filgrastim[Neulasta (G-CSF or GCSF)]; Leukine (Sargramostim)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Fernando Cabanillas

OTHER

Sponsor Role: lead

Responsible Party

Fernando Cabanillas

Hematolgy-Oncologyst

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fernando Cabanillas, MD

Role: PRINCIPAL_INVESTIGATOR

Auxilio

Fernando Cabanillas, MD

Role: PRINCIPAL_INVESTIGATOR

Auxilio Mutuo Cancer Center/Hospital Auxilio Mutuo

Locations

Hospital Auxilio Mutuo Cancer Center

San Juan, Puerto Rico, Puerto Rico

Countries

Puerto Rico

Other Identifiers

NCT01297478

Identifier Type: -

Identifier Source: org_study_id

NCT01297478

Identifier Type: -

Identifier Source: nct_alias