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View Clinical Trial (Medical Research Study)
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Rituximab and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma - NCT00118209-54601 (Clinical Trial 125700)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy125700.aspx
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| City: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Lymphoma |
| Purpose: |
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RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells
and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy
work in different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. Giving rituximab together with combination chemotherapy may
kill more cancer cells. It is not yet known which combination chemotherapy regimen is more
effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying rituximab when given together with two
different combination chemotherapy regimens to compare how well they work in treating
patients with diffuse large B-cell non-Hodgkin's lymphoma.
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| Study summary: |
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OBJECTIVES:
Primary
- Compare the event-free survival of patients with previously untreated de novo diffuse
large B-cell non-Hodgkin's lymphoma treated with R-CHOP comprising rituximab,
cyclophosphamide, doxorubicin, vincristine, and prednisone vs EPOCH-R comprising
etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab.
- Determine molecular predictors of outcome (using molecular profiling) in patients
treated with these regimens.
Secondary
- Compare the response rate and overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Correlate the clinical parameters (i.e., toxicity, response, survival outcomes, and
laboratory results) with molecular profiling in patients treated with these regimens.
- Determine the use of molecular profiling for pathological diagnosis in patients treated
with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
International Prognostic Index score. Patients are randomized to 1 of 2 treatment arms.
- Arm I (R-CHOP): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin IV over
3-5 minutes, and vincristine IV on day 1 and oral prednisone once daily on days 1-5.
Treatment repeats every 21 days for 6 courses in the absence of disease progression or
unacceptable toxicity.
- Arm II (EPOCH-R): Patients receive rituximab IV on day 1, doxorubicin IV, etoposide IV,
and vincristine IV continuously over 96 hours on days 1-4, cyclophosphamide IV on day
5, and oral prednisone twice daily on days 1-5. Patients also receive filgrastim
(G-CSF) once daily on days 2-11 or until blood counts recover. Treatment repeats every
21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 478 patients (239 per treatment arm) will be accrued for this
study within 4.5 years. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed* de novo B-cell non-Hodgkin's lymphoma (NHL) of 1 of the
following WHO histologic subtypes:
- Diffuse large cell lymphoma, including any of the following morphologic
variants:
- Centroblastic
- Immunoblastic
- T-cell/histiocyte rich
- Anaplastic
- Mediastinal (thymic) large cell lymphoma
- Intravascular large cell lymphoma NOTE: *Fine needle aspirates or core biopsies
must not be the only diagnostic material
- Stage I primary mediastinal (thymic) OR stage II-IV disease
- CD20-positive disease
- No underlying low-grade lymphoma (e.g., transformed lymphoma or low-grade lymphoma in
the bone marrow)
- No known lymphomatous CNS involvement
- Lumbar puncture required unless there are no neurological symptoms NOTE: A new
classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ.
The terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this
protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3^*
- Platelet count ≥ 100,000/mm^3^*
- No active bleeding unrelated to NHL NOTE: *Unless due to NHL
Hepatic
- Bilirubin ≤ 2 mg/dL* NOTE: *Unless due to NHL or Gilbert's disease
Renal
- Creatinine ≤ 1.5 mg/dL^* OR
- Creatinine clearance ≥ 50 mL/min^* NOTE: *Unless due to NHL
Cardiovascular
- No active ischemic heart disease
- No congestive heart failure
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No active uncontrolled bacterial or viral infection unrelated to NHL
- No other active medical process unrelated to NHL
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior rituximab
Chemotherapy
- No prior chemotherapy for other malignancies
- No prior cytotoxic chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- Prior short course (< 10 days) glucocorticoids allowed for an urgent local disease
complication (e.g., cord compression or superior vena cava syndrome) at diagnosis
- No concurrent hormonal therapy except steroids for adrenal failure or hormones for
non-disease related conditions (e.g., insulin for diabetes)
- No concurrent dexamethasone or other steroidal antiemetics
Radiotherapy
- Prior limited field radiotherapy allowed for an urgent local disease complication
(e.g., cord compression or superior vena cava syndrome) at diagnosis
- No concurrent radiotherapy except for isolated CNS lesions
Surgery
- Not specified
Other
- No other concurrent investigational or commercial agents or therapies for NHL |
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| Study is available at: |
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Gundersen Lutheran Center for Cancer and Blood
La Crosse, WI 54601
United States
Primary Contact:
Clinical Trials Office - Gundersen Lutheran Cancer Center
Email: cancerctr@gundluth.org
Phone: 608-775-2385 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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