Phase 2
N=68
Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
Non-Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00184002 ↗Enrolled (actual)
68
Serious AEs
51.5%
Results posted
Aug 2017
Primary outcome: Primary: Percentage of Patients With Complete Response to the Combination Chemotherapy — 75.0; 23.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Complete Response to the Combination Chemotherapy |
75.0; 23.0 | — |
| SECONDARY Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability |
35 | — |
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, complete disappearance of disease is expected in over 50% of people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been reformulated and been placed in a fatty bubble called a liposome. The reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be better at shrinking tumors and with reduced side effects. The purpose of this study is to see how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00184002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.