Lymphoma, Non Hodgkin's Lymphoma
Conditions
Keywords
Aggressive Non-Hodgkin's Lymphoma
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.
Interventions
DRUGCyclophosphamide, 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.
Sponsors
Genzyme, a Sanofi Company
Fernando Cabanillas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R | up to 3 years |
Countries
Puerto Rico
Outcome results
None listed