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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00576 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies the side effects and how well giving rituximab and dexamethasone together works in treating patients with low-grade non-Hodgkin lymphoma (NHL). 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, such as dexamethasone, 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 dexamethasone may kill more cancer cells
PRIMARY OBJECTIVES:
I. To estimate clinical response rate (RR) at 3 and 6 months. II. To estimate Grade 2-4 -infusion-related toxicity.
SECONDARY OBJECTIVES:
I. To evaluate laboratory parameters and correlate with clinical response including: antibody dependent cell mediated cytotoxicity and effector cell phenotype analysis at baseline, 4 weeks and three months.
II. To evaluate laboratory parameters and correlate with clinical response including: soluble cluster of differentiation (CD)20 fragments or CD20-containing membrane fragments at baseline, 4 weeks, and 3 months.
III. To evaluate laboratory parameters and correlate with clinical response including: phenotype analysis of CD16 and CD32 on natural killer (NK) cells.
IV. To evaluate laboratory parameters and correlate with clinical response including: rituximab pharmacokinetic studies at baseline, 4 weeks and 3 months.
OUTLINE:
Patients receive dexamethasone intravenously (IV) and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No previous treatment | Other | Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. |
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| Previous treatment | Other | Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacological study | Other | Correlative studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method | At 3 and 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Percentage of patients remaining alive estimated according to the Kaplan-Meier method | At 6 months, 12 months and 24 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Maloney | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Previous Treatment | Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. pharmacological study: Correlative studies rituximab: Given IV dexamethasone: Given IV laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| rituximab | Biological | Given IV |
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| dexamethasone | Drug | Given IV |
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| laboratory biomarker analysis | Other | Correlative studies |
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| FG001 | Previous Treatment | Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. pharmacological study: Correlative studies rituximab: Given IV dexamethasone: Given IV laboratory biomarker analysis: Correlative studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Previous Treatment | Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. pharmacological study: Correlative studies rituximab: Given IV dexamethasone: Given IV laboratory biomarker analysis: Correlative studies |
| BG001 | No Previous Treatment | Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. pharmacological study: Correlative studies rituximab: Given IV dexamethasone: Given IV laboratory biomarker analysis: Correlative studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Progression-free Survival | Survival without measurable progression of lymphoma estimated according to the Kaplan-Meier method | Posted | Number | 95% Confidence Interval | Kaplan-Meier estimated % of patients | At 3 and 6 months after enrollment |
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| Secondary | Survival | Percentage of patients remaining alive estimated according to the Kaplan-Meier method | Posted | Number | 95% Confidence Interval | Kaplan-Meier estimated % of patients | At 6 months, 12 months and 24 months after enrollment |
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|
6 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 | Previous Treatment | Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. pharmacological study: Correlative studies rituximab: Given IV dexamethasone: Given IV laboratory biomarker analysis: Correlative studies | 0 | 7 | 5 | 7 | ||
| EG001 | No Previous Treatment | Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. pharmacological study: Correlative studies rituximab: Given IV dexamethasone: Given IV laboratory biomarker analysis: Correlative studies | 0 | 25 | 16 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal episode | Cardiac disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Hypotension | Cardiac disorders | Non-systematic Assessment |
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| Cytokine release syndrome | Immune system disorders | Non-systematic Assessment |
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| Lymphopenia | Immune system disorders | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Thrombosis | Vascular disorders | Non-systematic Assessment |
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| Urticaria | Immune system disorders | Non-systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Allergic reaction | Immune system disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Penile infection | Infections and infestations | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Confusion | Nervous system disorders | Non-systematic Assessment |
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| Neuropathy | Nervous system disorders | Non-systematic Assessment |
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| Pain | General disorders | Non-systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Anorexia | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Sweating | General disorders | Non-systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
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| Hypoglycemia | Endocrine disorders | Non-systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hyperbilirubinemia | Hepatobiliary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Maloney | Fred Hutchinson Cancer Research Center | 206-667-5616 | dmaloney@fredhutch.org |
| ID | Term |
|---|---|
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008224 | Lymphoma, Follicular |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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