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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01181 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2015-0872 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies the long-term side effects of ruxolitinib in treating patients with myelofibrosis. Collecting data about the long-term safety and tolerability of ruxolitinib may better help future patients with myelofibrosis.
PRIMARY OBJECTIVES:
I. To collect long term safety and tolerability data in patients with myelofibrosis previously treated with ruxolitinib on protocol 2007-0169.
OUTLINE:
Patients continue to receive ruxolitinib orally (PO) once daily (QD) or twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (ruxolitinib, follow-up) | Experimental | Patients continue to receive ruxolitinib PO QD or BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-term Follow-up | Other | Undergo follow-up assessment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Most Common Treatment Related Adverse Events | A review of the most common adverse events related to study medication will be performed. Will follow standard reporting guidelines for adverse events. Safety data will be summarized by the number of participants affected. | to the date of failure or death from any cause, Up to 7 years, 3 months and 24 days |
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Inclusion Criteria:
Exclusion Criteria:
1. none
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| Name | Affiliation | Role |
|---|---|---|
| Prithviraj Bose | 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 | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Ruxolitinib, Follow-up) | Patients continue to receive ruxolitinib PO QD or BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles. Long-term Follow-up: Undergo follow-up assessment Quality-of-Life Assessment: Ancillary studies Ruxolitinib: Given PO |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Ruxolitinib, Follow-up) | Patients continue to receive ruxolitinib PO QD or BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles. Long-term Follow-up: Undergo follow-up assessment Quality-of-Life Assessment: Ancillary studies Ruxolitinib: Given PO |
| 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 | Most Common Treatment Related Adverse Events | A review of the most common adverse events related to study medication will be performed. Will follow standard reporting guidelines for adverse events. Safety data will be summarized by the number of participants affected. | Posted | Number | participants | to the date of failure or death from any cause, Up to 7 years, 3 months and 24 days |
|
Up to the date of failure or death from any cause, up to 7 years, 3 months and 24 days.
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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 (Ruxolitinib, Follow-up) | Patients continue to receive ruxolitinib PO QD or BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles. Long-term Follow-up: Undergo follow-up assessment Quality-of-Life Assessment: Ancillary studies Ruxolitinib: Given PO |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prithviraj Bose, MD/Professor | The University of MD Anderson Cancer Center | 713-792-7747 | PBose@mdnaderson.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 | May 2, 2018 | Nov 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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| Quality-of-Life Assessment |
| Other |
Ancillary studies |
|
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| Ruxolitinib | Drug | Given PO |
|
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| 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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| Units | Counts |
|---|---|
| Participants |
|
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| 2 |
| 8 |
| 6 |
| 8 |
| 8 |
| 8 |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Musculoskeletal and connective tissue disorder | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Sepsis | 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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| Surgical and medical procedures | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysarthria | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| 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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| Gait disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Infections and infestations | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Investigations | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Localized edema | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Night blindness | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Reproductive system and breast disorders | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Surgical and medical procedures | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Vascular disorders | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
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