Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated High- or High-Intermediate-Risk Diffuse Large B-Cell Lymphoma
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First Received Date ICMJE | February 15, 2012 | ||||
Last Updated Date | September 12, 2012 | ||||
Start Date ICMJE | January 2013 | ||||
Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
PFS following treatment with rituximab intense dosing and CHOP-21 in previously untreated patients with high risk DLBCL [ Time Frame: 1 year ] [ Designated as safety issue: No ] Defined as the time from entry onto study until lymphoma progression or death from any cause. |
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Original Primary Outcome Measures ICMJE |
PFS following treatment with rituximab intense dosing and CHOP-21 in previously untreated patients with high risk DLBCL [ Time Frame: 1 year ] [ Designated as safety issue: No ] Defined as the time from entry onto study until lymphoma progression or death from any cause. The null hypothesis is that dose-intense treatment will result in at most 65% PFS at 1 year in this high risk group of patients. The alternative is that it will result in at least 80% PFS at 1 year. The hypotheses are composite: in addition to overall assessment at 1 year, the null hypothesis asserts that dose-intense treatment will result in at most 80% PFS at 6 months, while the alternative is that 6 month PFS will be at least 95%. |
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Change History | Complete list of historical versions of study NCT01539174 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
CR in previously untreated patients with high risk DLBCL treated with rituximab intense dosing and CHOP-21 [ Time Frame: Baseline, between days 15 and 21 of course 3, and within 20-35 days after completion of treatment ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated High- or High-Intermediate-Risk Diffuse Large B-Cell Lymphoma | ||||
Official Title ICMJE | A Phase II Study of Rituximab Intense Dosing With CHOP-21 (RID-CHOP) in Patients With Previously Untreated High or High-Intermediate Risk IPI (3-5) Diffuse Large B-Cell Lymphoma (DLBCL) | ||||
Brief Summary | This phase II trial studies how well giving rituximab together with combination chemotherapy works in treating patients with previously untreated high- or high-intermediate-risk diffuse large B-cell lymphoma (DLBCL). Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells. Giving rituximab together with combination chemotherapy together may be an effective treatment for DLBCL |
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Detailed Description | PRIMARY OBJECTIVES: I. To evaluate 1 year progression-free survival (PFS) following treatment with rituximab intense dosing and CHOP-21 (RID-CHOP) in previously untreated patients with high risk (International Prognostic Index [IPI] 3-5) DLBCL. SECONDARY OBJECTIVES: I. To evaluate, in previously untreated patients with high risk (IPI 3-5) DLBCL treated with rituximab intense dosing and CHOP-21: Complete response (CR) rate, (as defined by International Harmonization Project criteria using 18-fluorodeoxyglucose [FDG] -positron emission tomography [PET]/computed tomography [CT]). II. Overall survival. III. Toxicity profile. IV. Rituximab pharmacokinetics for this dose and schedule. V. Effect of immunophenotype of DLBCL on outcome. VI. Effect of Fc-Gamma Receptor III (FcyRIII) polymorphism genotype on outcome. OUTLINE: Patients receive rituximab intravenously (IV) on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone orally (PO) on days 1-5. 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 up every 2-3 months for 2 years, every 6 months for 3 years, annually for up to 10 years. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | Experimental: Treatment (monoclonal antibody, combination chemotherapy)
Patients receive rituximab IV on days 0, 1, 4, 8, and 15 of course 1; days 1, 8, and 15 of course 2; and day 1 of all subsequent courses. Patients also receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE | 61 | ||||
Completion Date | |||||
Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | |||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01539174 | ||||
Other Study ID Numbers ICMJE | OER-HM-039, NCI-2011-03309 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Fox Chase Cancer Center | ||||
Study Sponsor ICMJE | Fox Chase Cancer Center | ||||
Collaborators ICMJE | Genentech | ||||
Investigators ICMJE |
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Information Provided By | Fox Chase Cancer Center | ||||
Verification Date | September 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |