CHOP-R: Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL

Sponsor

Fernando Cabanillas (Other)

Overall Status

Completed

CT.gov ID

NCT01527422

Collaborator

Genzyme, a Sanofi Company (Industry)

Enrollment

Location

61.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Non Hodgkin's Lymphoma	Drug: Cyclophosphamide, Doxorubicin, Vincristine and Prednisone	Phase 1/Phase 2

Detailed Description

1.1 Primary Objective:

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:

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Protocol CCAM 05-02 " Phase I-II Study of Dose Dense of PEG Filgrastim and GM-CSF as Support for Dose Desnse CHOP-R Front Line Therapy for Aggressive Non Hodgkin's Lymphoma"

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Mar 1, 2011

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Auxilio Mutuo Cancer Center	San Juan		Puerto Rico	00919

Sponsors and Collaborators

Fernando Cabanillas
Genzyme, a Sanofi Company

Investigators

Principal Investigator: Fernando Cabanillas, MD, Auxilio
Principal Investigator: Fernando Cabanillas, MD, Auxilio Mutuo Cancer Center/Hospital Auxilio Mutuo