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| ID | Type | Description | Link |
|---|---|---|---|
| 75967 | Other Identifier | Stanford IRB, historical | |
| U2082N | |||
| LYMHD0003 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.
This study will evaluate the partial, complete, and overall response rates to rituximab of subjects with lymphocyte-predominant Hodgkin's lymphoma. Subjects will receive rituximab by IV infusion over several hours once a week for 4 weeks, followed by maintenance therapy as repeat course of the same dose and schedule rituximab at 6, 12, and 18 months.
This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab 375 mg/m2 per week | Experimental | 375 mg/m2 rituximab by IV infusion weekly. The initial course of treatment is 4 weeks. Subjects who achieve an objective response or stable disease after the initial course (4 weeks) were permitted to continue additional 4-week cycles of treatment, for 3 additional courses starting every 6 months (ie, at 6; 12; and 18 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS, assessed as the number of patients 5 years after treatment who are alive and without a ≥ 50% increase from nadir in the sum of the product of the greatest lesion diameters (SPD) of any previously-identified abnormal node, or appearance of any new lesion | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS, assessed as the number of patients 5 years after treatment who are alive | 5 years |
| Overall Response Rate (ORR) | Overall response as assessed as Complete Response (CR) + Partial Response (PR)
|
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Ranjana H Advani, MD | Stanford University | Study Director |
| Richard T Hoppe, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24516013 | Result | Advani RH, Horning SJ, Hoppe RT, Daadi S, Allen J, Natkunam Y, Bartlett NL. Mature results of a phase II study of rituximab therapy for nodular lymphocyte-predominant Hodgkin lymphoma. J Clin Oncol. 2014 Mar 20;32(9):912-8. doi: 10.1200/JCO.2013.53.2069. Epub 2014 Feb 10. | |
| Result | Horning SJ, Bartlett NL, Breslin S, et al. Results of a prospective phase II trial of limited and extended rituximab treatment in nodular lymphocyte predominant Hodgkin's disease (NLPHD). Blood [ASH Annual Meeting Abstracts]. 2007;110:abs644. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab 375 mg/m2 Per Week Inital Group | Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months Initial Group of participants prior to the addition of the three extra cycle treatments. |
| FG001 | Rituximab 375 mg/m2 Per Week Secondary Group | Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months Secondary Group of participants were added after the addition of the three extra cycle treatments. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 (Initial Treatment) |
| |||||||||||||
| Cycle 2 (Maintenance Treatment) |
| |||||||||||||
| Cycle 3 (Maintenance Treatment) |
| |||||||||||||
| Cycle 4 (Maintenance Treatment) |
|
This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab 375 mg/m2 Per Week | Rituximab 375 mg/m2 per week by IV infusion for 4 consecutive weeks |
| 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 | Progression-free Survival (PFS) | PFS, assessed as the number of patients 5 years after treatment who are alive and without a ≥ 50% increase from nadir in the sum of the product of the greatest lesion diameters (SPD) of any previously-identified abnormal node, or appearance of any new lesion | This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group. | Posted | Number | participants | 5 years |
|
5 years
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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 | Rituximab 375 mg/m2 Per Week | Rituximab 375 mg/m2 week by IV infusion for 4 consecutive weeks, every 6 months for 2 years. This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAEv4 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAEv4 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ranjana Advani, MD, Professor of Lymphoma | Stanford University | 650-725-6456 | radvani@stanford.edu |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D059451 | Biosimilar Pharmaceuticals |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| 4 weeks |
| Stanford |
| California |
| 94305 |
| United States |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Overall Survival (OS) | OS, assessed as the number of patients 5 years after treatment who are alive | This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group. | Posted | Number | participants | 5 years |
|
|
|
| Secondary | Overall Response Rate (ORR) | Overall response as assessed as Complete Response (CR) + Partial Response (PR)
| This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group. | Posted | Number | percentage of participants | 4 weeks |
|
|
|
| 28 |
| 39 |
| 39 |
| 39 |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAEv4 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEv4 | Systematic Assessment |
|
| Colon cancer, metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Relapse/progressive disease, Hodgkin lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Acute myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Relapse / transformation to aggressive B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAEv4 | Systematic Assessment | Including: Abdominal, back, ear, knee, lower quadrant, hand, shoulder, thigh |
|
| Anemia | Blood and lymphatic system disorders | CTCAEv4 | Systematic Assessment |
|
| Abdominal bloating | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Aches | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Acid reflux | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Allergy | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Aphthous | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Arm tingling | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Athlete's foot | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Bloody stool | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Body odor | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Buccal mucosa ulceration | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Burning sensation | General disorders | CTCAE (4.0) | Non-systematic Assessment | from knee to feet |
|
| Cardiac disorder | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | including: chest discomfort, chest heaviness, chest pain and chest tightness |
|
| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Claudication | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Cold | General disorders | CTCAE (4.0) | Non-systematic Assessment | Including: cold symptoms |
|
| Colon cancer | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Including: dry cough and/or with sputum |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Distress | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Double vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysesthesias | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Early satiety | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Elevated levels | Investigations | CTCAE (4.0) | Non-systematic Assessment | Including: cholesterol, glucose, Lactate dehydrogenase (LDH) and Prostate-Specific Antigen (PSA) |
|
| Epigastric gurgling | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Facial hives | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Feeling sleepy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flushing | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| GI bleeding | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| GI irritability | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Graves hyperthyroidism | Endocrine disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headaches | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hearing loss | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Heart murmur | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hip bursitis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Indigestion | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Infusion related reactions | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Including: Itchy ear, eye, face, nose , scalp and throat |
|
| arthralgias | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Leukopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Maxillary sinus disease | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Memory loss | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Metastatic adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
|
| Morning stiffness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Muscle aches | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Myalgias | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Including discharge |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neck stiffness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Night sweats | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Numbness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | Including: numbness in hands and thighs |
|
| Odynophagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Oral ulceration | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Oropharyngeal ulceration | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Peripheral neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pressure in bilateral upper lungs | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Right neck fullness | Endocrine disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rigors | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Runny nose | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Scratchy throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | Including: sores |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Soreness in extremities | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Stress urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Superficial phlebitis | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Swelling | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tightness in throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tooth abscess | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight gain | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| Title | Measurements |
|---|---|
|