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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01841 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2011-0520 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well ofatumumab works as front-line therapy in treating elderly participants with chronic lymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of cancer cells to grow and spread.
PRIMARY OBJECTIVES I. To evaluate the overall response rate of ofatumumab in the upfront setting in elderly, unfit patients with chronic lymphocytic leukemia (CLL).
SECONDARY OBJECTIVES:
I. To determine the overall survival with ofatumumab in upfront setting in elderly, unfit CLL patients.
II. To evaluate the complete response rate and time to progression to therapy of ofatumumab in elderly, unfit patients with CLL.
III. To determine the plasma levels of ofatumumab in elderly, unfit patients. IV. To evaluate predictive capability of micro ribonucleic acid (RNA) (miRNAs) detection in plasma samples.
OUTLINE:
Participants receive ofatumumab intravenously (IV) over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (ofatumumab) | Experimental | Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab | Biological | Given IV |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Participants With a Response | Response = (complete response [CR] + partial response [PR]) per 2008 National Cancer Institute (NCI)-Working Group (WG) criteria. Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. Partial Response (PR): At least 50 % reduction in disease signs/symptoms and normalization of peripheral blood. | Up to 3 years, 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Time from date of treatment start until the date of first objective documentation of disease-relapse. | Up to 3 years, 10 months |
| Participants With a Complete Response (CR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandra Ferrajoli | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Ofatumumab) | Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Ofatumumab: Given IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Ofatumumab) | Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Ofatumumab: Given IV |
| 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 | Participants With a Response | Response = (complete response [CR] + partial response [PR]) per 2008 National Cancer Institute (NCI)-Working Group (WG) criteria. Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. Partial Response (PR): At least 50 % reduction in disease signs/symptoms and normalization of peripheral blood. | Of the 34 participants registered, 32 were evaluable for response. | Posted | Count of Participants | Participants | Up to 3 years, 10 months |
|
Up to 3 years, 10 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 | Treatment (Ofatumumab) | Participants receive ofatumumab IV over 4 hours once a week for 4 weeks, then monthly thereafter. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. Ofatumumab: Given IV |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdoninal Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allessandra Ferrajoli, MD./Professor | The University of Texas MD Anderson Cancer Center | 713-792-2063 | aferrajo@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2013 | Jun 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C527517 | ofatumumab |
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Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow.
| Up to 3 years, 10 months |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Progression-free Survival (PFS) | Time from date of treatment start until the date of first objective documentation of disease-relapse. | Of the 34 participants registered, 32 were evaluable for response. | Posted | Median | 95% Confidence Interval | Months | Up to 3 years, 10 months |
|
|
|
| Secondary | Participants With a Complete Response (CR) | Complete Response (CR): Absence of disease signs/symptoms, normalization of peripheral blood and bone marrow. | Of the 34 participants registered, 32 were evaluable for response. | Posted | Count of Participants | Participants | Up to 3 years, 10 months |
|
|
|
| 0 |
| 34 |
| 9 |
| 34 |
| 29 |
| 34 |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Papillary Urothelial Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Transient Ichemic Attack | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hip Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aortic Valve Disease | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lung Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic Event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| edema | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Infusion Related Reaction | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Other Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Infections | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Skin Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary Incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |