Clinical trial NCT01527422: Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lymphoma
Non Hodgkin's Lymphoma
Keywords: Aggressive Non-Hodgkin's Lymphoma
Lead sponsor: Auxilio Mutuo Cancer Center
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2012-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Hospital Auxilio Mutuo Cancer Center
Study officials:
affiliation: Auxilio
name: Fernando Cabanillas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Auxilio Mutuo Cancer Center/Hospital Auxilio Mutuo
name: Fernando Cabanillas, MD
role: PRINCIPAL_INVESTIGATOR
References: