Myelofibrosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERQuality-of-Life Assessment
Ancillary studies
DRUGRuxolitinib
Given PO
OTHERLong-term Follow-up
Undergo follow-up assessment
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Currently enrolled in study 2007-0169 and benefiting from therapy as determined by treating physician 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment of this study 3. Ability and agreement to attend protocol-specified visits at the study site 4. Able to comprehend and willing to sign the informed consent form 5. Negative pregnancy test in females of childbearing potential; male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose; acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner's vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test 7 days before first study treatment
Exclusion criteria
1\. none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Most Common Treatment Related Adverse Events | to the date of failure or death from any cause, Up to 7 years, 3 months and 24 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Treatment (Ruxolitinib, Follow-up) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 73 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 8 |
| other Total, other adverse events | 8 / 8 |
| serious Total, serious adverse events | 6 / 8 |
Outcome results
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.
Time frame: to the date of failure or death from any cause, Up to 7 years, 3 months and 24 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment (Ruxolitinib, Follow-up) | Most Common Treatment Related Adverse Events | Fatigue | 2 participants |
| Treatment (Ruxolitinib, Follow-up) | Most Common Treatment Related Adverse Events | Infections | 1 participants |
| Treatment (Ruxolitinib, Follow-up) | Most Common Treatment Related Adverse Events | Headache | 1 participants |
| Treatment (Ruxolitinib, Follow-up) | Most Common Treatment Related Adverse Events | Dizziness | 1 participants |