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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01527422
Other study ID # NCT01297478
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 3, 2012
Last updated February 3, 2012
Start date January 2006
Est. completion date March 2011

Study information

Verified date February 2012
Source Auxilio Mutuo Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT01297478

Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Cyclophosphamide, 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.

Locations

Country Name City State
Puerto Rico Hospital Auxilio Mutuo Cancer Center San Juan

Sponsors (2)

Lead Sponsor Collaborator
Fernando Cabanillas Genzyme, a Sanofi Company

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R up to 3 years No
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