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

Fernando Cabanillas

Status and phase

Completed

Phase 2

Phase 1

Conditions

Lymphoma

Non Hodgkin's Lymphoma

Treatments

Drug: Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01527422

NCT01297478

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No 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