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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03233 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This study will determine the overall response rate and toxicity of rituximab and Velcade in combination in patients with relapsed or refractory mantle cell non-Hodgkin's lymphoma.
Rationale: Previous studies testing bortezomib and rituximab separately indicate these agents have some efficacy against mantle cell lymphoma (MCL). Bortezomib is a targeted cancer drug that blocks proteasomes. The proteasome is an enzyme complex existing in all cells that influences proteins controlling cellular processes. By blocking the proteasome, bortezomib disrupts biologic pathways such as those related to the growth and survival of cancer cells. Rituximab is a monoclonal antibody that attaches to a protein called the CD20 antigen that is found almost exclusively on the surface of B-cells with leukemia. Once rituximab attaches to the protein, the immune system activates to kill the malignant B-cells. The current study combines bortezomib and rituximab in patients with relapsed or refractory MCL.
Purpose: This study will evaluate the safety and efficacy of bortezomib and rituximab in patients with relapsed or refractory MCL. Blood, molecular, and tumor analysis will be conducted to provide researchers with information about areas such as rituximab resistance, the effects of bortezomib on cells associated with immune function, and protein alterations related to the cellular growth and death of MCL. In addition, the role of maintenance therapy and timing of administration in MCL will be assessed.
Treatment: Patients in this study will receive bortezomib and rituximab. Both drugs will be administered through intravenous infusions. There are two treatment periods in this study. The first is considered induction therapy where patients will receive bortezomib and rituximab intermittently over an eighteen week period. Lower dosages of rituximab will be given to patients at the beginning of the study to ensure no severe toxicity occurs. Those patients without disease growth after the eighteen weeks of treatments will continue with maintenance therapy. During this time period, patients will be given bortezomib and rituximab for up to one year and a half. Several tests and exams will be conducted throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Velcade and Rituximab | Experimental | Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velcade | Drug | Induction: 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13 & 14. Maintenance: 1.3 mg/m2 IV day 1 weekly x 2 weeks beginning week 20 and continuing every 6 months until month 23. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | To determine the overall survival in patients with relapsed or refractory mantle cell and follicular lymphoma following treatment with rituximab and Velcade™. | Every 3 months |
| Assess the Toxicity of Combination Rituximab and Velcade™ in Patients With Previously Treated Mantle Cell and Follicular Lymphoma. | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting. | Day 1 of each cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival(PFS) | To correlate serial plasma rituximab levels with response and progression-free survival. | 2 years |
| Correlative Studies | During induction (weeks 1-15); PK every 2 months during maintenance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristie Blum, MD | The Ohio State University Comprehensive Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24048792 | Result | Baiocchi RA, Alinari L, Lustberg ME, Lin TS, Porcu P, Li X, Johnston JS, Byrd JC, Blum KA. Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma. Cancer. 2011 Jun 1;117(11):2442-51. doi: 10.1002/cncr.25792. Epub 2010 Dec 14. |
| Label | URL |
|---|---|
| Jamesline | View source |
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From December 2005 until June 2009, 25 patients aged ≥ 18 years with historically confirmed, grade 1 or 2 mantel cell or follicular NHL according to the World Health Organization classification who relapsed or were refractory after at least 1 previous therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Velcade and Rituximab | Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Velcade and Rituximab | Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate | To determine the overall survival in patients with relapsed or refractory mantle cell and follicular lymphoma following treatment with rituximab and Velcade™. | Posted | Number | percentage of patients | Every 3 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Velcade and Rituximab | Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration. Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | General disorders | CTCAE Version 3.0 | Systematic Assessment | Grade 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristie Blum, MD | The Ohio State University Comprehensive Cancer Center | 614-293-4519 | Kristie.Blum@osumc.edu |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D020522 | Lymphoma, Mantle-Cell |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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|
| Rituximab | Drug | Induction: 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13 and 14 prior to Velcade administration. Maintenance: 375 mg/m2 day 1 weekly x 4 weeks. |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lymphoma Disease Stages | Ann Arbor staging system | Number | participants |
|
| B-symptoms | Number | participants |
|
| Disease Type | Number | participants |
|
|
| Primary | Assess the Toxicity of Combination Rituximab and Velcade™ in Patients With Previously Treated Mantle Cell and Follicular Lymphoma. | The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting. | grade 3 neurotoxicity which consisted of constipation/ileus, sensory or motor neuropathy, or orthostatic hypotension | Posted | Number | patients | Day 1 of each cycle |
|
|
|
| Secondary | Progression-free Survival(PFS) | To correlate serial plasma rituximab levels with response and progression-free survival. | Posted | Number | 95% Confidence Interval | percentage of patients | 2 years |
|
|
|
| Secondary | Correlative Studies | Data not collected and analyzed | Posted | During induction (weeks 1-15); PK every 2 months during maintenance. |
|
|
| 0 |
| 25 |
| 25 |
| 25 |
| Anemia | Blood and lymphatic system disorders | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
| Thrombocytopenia | Injury, poisoning and procedural complications | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
| Anorexia | Metabolism and nutrition disorders | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
| Rash | Skin and subcutaneous tissue disorders | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
| Sensory Neuropathy | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
| Motor Neuropathy | Musculoskeletal and connective tissue disorders | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
| Autonomic neuropathy | Nervous system disorders | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 orthostatic hypotension |
|
| Febrile neutropenia | Blood and lymphatic system disorders | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
| Fatigue | General disorders | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
| Myositis/Creatinine kinase elevation | Investigations | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
| nausea/vomiting | Gastrointestinal disorders | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
| Constipation/ileus | Gastrointestinal disorders | NCI CTCAE Version 3. | Systematic Assessment | Grade 3 |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |