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"
18 Years
N/A
Both
Lymphoma, Non Hodgkin's Lymphoma
Trial Information
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"
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R
Outcome Time Frame:
up to 3 years
Safety Issue:
No
Principal Investigator
Fernando Cabanillas, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Auxilio
Authority:
United States: Food and Drug Administration
Study ID:
NCT01297478
NCT ID:
NCT01527422
Start Date:
January 2006
Completion Date:
March 2011
Related Keywords:
- Lymphoma
- Non Hodgkin's Lymphoma
- Aggressive Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|
