Status:
COMPLETED
Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, c...
Eligibility Criteria
Inclusion
- Pathologic diagnosis of Non-Hodgkin's lymphoma of B-cell origin: follicular large cell, diffuse large cell (including all B-cell variants), Burkitt or Burkitt-like lymphoma
- All stages of disease
- Measurable or evaluable tumor parameter(s)
- Age greater than 17 years old
- Karnofsky performance status greater or equal to 50%
- AGC greater or equal to 1.0; platelets greater or equal to 75,000(unless abnormal because of lymphoma)
- Bilirubin less or equal to 2.0; SGOT less or equal to 3 times upper limit of normal (unless abnormal because of lymphoma)
- Creatinine less or equal to 2.0 or creatinine clearance greater or equal to 60 ml/min (unless abnormal because of lymphoma)
- LVEF greater or equal to 45%
- Concurrent RT with or without steroids for emergency conditions secondary to lymphoma (i.e., CNS tumor, cord compression)are permitted
- Men and women of childbearing potential must agree to use adequate birth control for the duration of the therapy and for 3 months after completion of therapy
- Signed informed consent
Exclusion
- Prior systemic cytotoxic therapy or RT for lymphoma
- Second active tumor, other than non-melanomatous skin ca and in-situ cervical cancer
- HIV seropositive
- Primary CNS lymphoma
- Pregnant or nursing women
- Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent, in the opinion of the PI
Key Trial Info
Start Date :
January 10 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2013
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00184002
Start Date
January 10 2003
End Date
May 7 2013
Last Update
August 10 2017
Active Locations (1)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033