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Phase II Study of Epratuzumab and Rituximab in Combination With Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (CHOP) in Patients With Previously Untreated Stage II, III, or IV Diffuse Large B-Cell Lymphoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Related Publications Trial Contact Information Registry Information
Alternate Title
Monoclonal Antibody Therapy and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Closed
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18 and over
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NCI
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NCCTG-N0489 N0489, NCT00301821
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Objectives Primary - Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma.
- Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.
- Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen.
- Assess the safety of this treatment regimen.
Secondary - Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen.
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy:
- No prior therapy for diffuse large B-cell lymphoma, including the following:
- Chemotherapy
- Immunotherapy
- Biologic therapy
- Radiotherapy
- Prior short course (≤ 14 days) of corticosteroids allowed
- Prior splenectomy allowed
- No prior pelvic irradiation
- No other concurrent investigational agents
- No concurrent chemotherapy, immunotherapy, or radiotherapy
- No concurrent enrollment on another treatment study involving a pharmacologic agent (e.g., drugs, biologics, immunotherapy, or gene therapy)
Patient Characteristics:
- ECOG performance status (PS) 0-3
- For patients with ECOG PS 3, the PS must be disease related
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Total bilirubin ≤ 2 mg/dL (if total bilirubin > 2 mg/dL, direct bilirubin should be within normal limits)
- AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if there is liver involvement)
- Creatinine ≤ 2 times ULN
- Life expectancy ≥ 12 weeks
- Negative pregnancy test
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- No active serious infection requiring antibiotics
- No New York Heart Association class III or IV heart disease
- No other primary malignancy within the past 5 years, except for squamous cell or basal cell carcinoma of the skin, in situ carcinoma of the cervix, or previously treated prostate cancer with a stable prostate-specific antigen
- No known HIV positivity
- No known hepatitis B or C infection
- Ejection fraction ≥ 45% by MUGA or echocardiogram (required if patients has a history of heart disease or is ≥ 50 years old)
- Willing to provide blood and tissue samples for mandatory translational research component of study
Expected Enrollment 86A total of 86 patients will be accrued for this study. Outcomes Primary Outcome(s)Response rate as assessed by complete response (CR) and partial response (PR) rates at end of treatment Event-free survival after 12 months Overall survival after 12 months
Secondary Outcome(s)Toxicity as assessed by incidence of neutropenia during each course of treatment
Outline This is a multicenter study. Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 5 years. Related PublicationsMicallef IN, Kahl BS, Maurer MJ, et al.: A pilot study of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy in patients with previously untreated, diffuse large B-cell lymphoma. Cancer 107 (12): 2826-32, 2006.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations North Central Cancer Treatment Group | | | Ivana Micallef, MD, Protocol chair | | | | Daniel Nikcevich, MD, PhD, Protocol co-chair | | | | Thomas Witzig, MD, Protocol co-chair | | | |
Registry Information | | Official Title | | A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma | | Trial Start Date | | 2006-01-20 | | Registered in ClinicalTrials.gov | | NCT00301821 | | Date Submitted to PDQ | | 2005-11-15 | | Information Last Verified | | 2007-08-13 | | NCI Grant/Contract Number | | CA25224 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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