Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL

Lymphoma Clinical Trial

— CHOP-R  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527422
• Other study ID #: NCT01297478
• 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

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin's Lymphoma

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