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Janus Kinase (JAK) Inhibitor
Ruxolitinib Phosphate for Chronic Lymphocytic Leukemia Fatigue
Phase 2
Waitlist Available
Led By Zeev Estrov
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Subjects must be diagnosed with CLL and do not meet the IWCLL criteria for treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study Summary
This trial studies ruxolitinib phosphate to see how well it works in reducing fatigue for patients with CLL.
Who is the study for?
This trial is for patients with chronic lymphocytic leukemia who experience fatigue, have stable blood counts, and are not in immediate need of CLL treatment. They must understand the study and consent to participate. Pregnant or breastfeeding women, those with recent serious illnesses or infections, and individuals on certain medications are excluded.Check my eligibility
What is being tested?
The trial tests Ruxolitinib Phosphate's effectiveness in reducing fatigue associated with chronic lymphocytic leukemia by blocking a protein called JAK that cancer cells need to grow. It also evaluates changes in lymph node size and leukemia cell counts.See study design
What are the potential side effects?
Ruxolitinib may cause side effects such as low blood cell counts leading to increased infection risk, anemia causing tiredness, bruising or bleeding issues due to low platelets, liver function abnormalities, kidney problems and potential drug interactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
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I have been diagnosed with CLL but do not require treatment yet.
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I experience noticeable symptoms from my condition.
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I stopped all CLL treatments 30 days ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in fatigue
Secondary outcome measures
20% improvement in symptoms
Proportion of patients with 2 point reductions in the BFI #3 score
Side effects data
From 2021 Phase 2 trial • 71 Patients • NCT0143120923%
anemia
13%
Fever
11%
platelet count decreased
9%
neutrophil count decreased
9%
sepsis
9%
lymphocyte count decreased
9%
dyspnea
6%
thromboembolic event
4%
hypercalcemia
4%
hypoxia
4%
fever
4%
hypophosphatemia
4%
Acute kidney injury
4%
sinus tachycardia
4%
respiratory failure
4%
fatigue
4%
lung infection
4%
ileus
4%
hypotension
2%
nausea
2%
Investigations
2%
hypertension
2%
cognitive disturbance
2%
pneumonitis
2%
Hepatobiliary - Other
2%
anorexia
2%
dizziness
2%
abdominal pain
2%
diarrhea
2%
pain in extremity
2%
confusion
2%
creatinine increased
2%
delirium
2%
pleural effusion
2%
upper respiratory infection
2%
vomiting
2%
wound infection
2%
Fall
2%
cardiac disorder, Other
2%
seizure
2%
skin infection
2%
syncope
2%
tumor lysis syndome
2%
Infections and infestiations - Other
2%
Anemia
2%
Musculoskeletal, Other
2%
fracture
2%
gait disturbance
2%
gastric hemorrhage
2%
sore throat
2%
leukemia secondary to oncology chemotherapy
2%
lymphedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diffuse Large B-cell Lymphoma (DLBCL)
Peripheral T-cell Non-Hodgkin Lymphoma (PTCL)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (ruxolitinib phosphate)Experimental Treatment2 Interventions
Patients receive ruxolitinib phosphate PO BID (approximately 12 hours apart) for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib Phosphate
2011
Completed Phase 2
~390
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,143 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,771 Total Patients Enrolled
Zeev EstrovPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
1 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself and perform daily activities.I have been diagnosed with CLL but do not require treatment yet.I experience noticeable symptoms from my condition.I stopped all CLL treatments 30 days ago.I needed blood transfusions due to low blood counts, not because of surgery.I am not taking any medications that are not allowed in the study, except when approved by the study doctor.I am a woman over 55 with no menstrual period for a year or have been surgically sterile for 3 months.I do not have an active, uncontrolled infection or HIV.I haven't had cancer in the last 2 years, except for certain skin, cervical, or thyroid cancers that were completely removed.I will need standard treatment during the study.I may or may not have received treatment for my condition before.I am not pregnant or breastfeeding.I have a heart condition that is not well-controlled.I have been treated with JAK inhibitor therapy before.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (ruxolitinib phosphate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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