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

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ClinicalTrials.gov Identifier: NCT01527422
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : February 7, 2012
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Fernando Cabanillas, Auxilio Mutuo Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lymphoma Non Hodgkin's Lymphoma Drug: Cyclophosphamide, Doxorubicin, Vincristine and Prednisone Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Primary Completion Date : November 2010
Actual Study Completion Date : March 2011



Intervention Details:
    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.
    Other Names:
    • Cyclophosphamide (Cytoxan)
    • Doxorubicin (Adryamicin)
    • Vincristine (Oncovin)
    • Prednisone
    • Rituximab (Rituxan)
    • Peg Filgrastim[Neulasta (G-CSF or GCSF)]
    • Leukine (Sargramostim)


Primary Outcome Measures :
  1. Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF combined with CHOP-R [ Time Frame: up to 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527422


Locations
Puerto Rico
Hospital Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00919
Sponsors and Collaborators
Fernando Cabanillas
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Fernando Cabanillas, MD Auxilio
Principal Investigator: Fernando Cabanillas, MD Auxilio Mutuo Cancer Center/Hospital Auxilio Mutuo

Responsible Party: Fernando Cabanillas, Hematolgy-Oncologyst, Auxilio Mutuo Cancer Center
ClinicalTrials.gov Identifier: NCT01527422     History of Changes
Obsolete Identifiers: NCT01297478
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Fernando Cabanillas, Auxilio Mutuo Cancer Center:
Aggressive Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Liposomal doxorubicin
Doxorubicin
Prednisone
Vincristine
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids