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Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Rituximab Pateinets With Aggresive NHL (CHOP-R)

Primary Purpose

Lymphoma, Non Hodgkin's Lymphoma

Status

Completed

Phase

Phase 1

Locations

Puerto Rico

Study Type

Interventional

Intervention

Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Aggressive Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Auxilio Mutuo Cancer Center

Outcomes

Primary Outcome Measures

Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R

Secondary Outcome Measures

Full Information

NCT ID

NCT01527422

First Posted

February 3, 2012

Last Updated

February 3, 2012

Sponsor

Fernando Cabanillas

Collaborators

Genzyme, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT01527422

Brief Title

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

Acronym

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"

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Fernando Cabanillas

Collaborators

Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Non Hodgkin's Lymphoma

Keywords

Aggressive Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

Other Intervention Name(s)

Cyclophosphamide (Cytoxan), Doxorubicin (Adryamicin), Vincristine (Oncovin), Prednisone, Rituximab (Rituxan), Peg Filgrastim[Neulasta (G-CSF or GCSF)], Leukine (Sargramostim)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando Cabanillas, MD

Organizational Affiliation

Auxilio

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fernando Cabanillas, MD

Organizational Affiliation

Auxilio Mutuo Cancer Center/Hospital Auxilio Mutuo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Auxilio Mutuo Cancer Center

City

San Juan

ZIP/Postal Code

00919

Country

Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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