Can a cancer drug beat CLL fatigue? small trial hopes to find out
NCT ID NCT02131584
First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This phase II trial tests whether ruxolitinib (Jakafi) can reduce fatigue in people with chronic lymphocytic leukemia (CLL) who are not yet ready for standard treatment. Ten participants will take the drug and report their fatigue levels using a simple questionnaire. The goal is to see if the drug improves symptoms like tiredness and swollen lymph nodes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ruxolitinib (Jakafi)
- What this could lead to
- If it works, this could offer a way to ease severe fatigue and other symptoms in CLL patients who do not yet need full cancer treatment.
- What could go wrong
- This is a very small, early-phase study with only 10 participants. It focuses on symptom relief, not curing the disease, and results may not apply to all CLL patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
10 people
The number who actually took part.
- Started
-
Sep 2014
- Expected to finish
-
Sep 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects who are able to understand and sign an informed consent document * Subjects must be diagnosed with CLL and do not meet the IWCLL criteria for treatment * Patients may have been previously treated or previously untreated * Symptomatic patients with a BFI symptom scale of 2 points or greater * Subjects with hemoglobin values at the screening visit equal to or greater than 12.0 g/dL * Subjects with a platelet count of at least 75 x 10\^9/L at the screening visit * Subjects with an absolute neutrophil count (ANC) of equal to or higher than 0.5 x 10\^9/L at the screening visit * Subjects must have discontinued all drugs used to treat CLL no later than day -30 * Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Exclusion Criteria: * Females who are pregnant or are currently breastfeeding * Subjects of childbearing potential who are unwilling to take appropriate precautions (throughout the study from screening, including 30 days after discontinuation of the study drug) to avoid becoming pregnant or fathering a child * Females of non-childbearing potential are defined as women who (a) are equal to or greater than 55 years of age with history of amenorrhea for 1 year, or (b) are surgically sterile for at least 3 months * For females of childbearing potential, or for males, appropriate precautions are those that are at least 99% effective in preventing the occurrence of pregnancy; these methods should be communicated to the subjects and their understanding confirmed: * Complete abstinence from sexual intercourse * Double barrier methods * Condom with spermicide in conjunction with use of an intrauterine device (IUD) * Condom with spermicide in conjunction with use of a diaphragm * Oral, injectable, or implanted contraceptives * Tubal ligation or vasectomy (surgical sterilization) * Subjects with recent history of inadequate bone marrow reserve as demonstrated by previous transfusions except for acute blood loss (e.g. surgery) in the month prior to screening * Alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN) * Modification of diet in renal disease (MDRD) calculated glomerular filtration rate (GFR) \< 30 mL/min * Subjects with active uncontrolled infection or who are human immunodeficiency virus (HIV) positive (subjects with acute infections requiring treatment should delay screening/enrollment until the course of therapy has been completed and the event is considered controlled) * Subjects with an invasive malignancy over the previous 2 years except treated basal or squamous carcinomas of the skin completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers; other completely resected cancers greater than 2 years may be considered after review by the principal investigator (PI) * Subjects with clinically significant uncontrolled cardiac disease * Subjects being treated concurrently with any prohibited medications, including investigational medication, rifampin, St. John's wort, and potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (excluding ketoconazole) unless continuation of such medications are determined by the investigator to be in the best interest of the patient * Subjects who have previously received JAK inhibitor therapy * Subjects with active alcohol or drug addiction that would interfere with their ability to comply with the study requirements * Subjects with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol * Subjects who have unknown transfusion history for at least the 12 weeks prior to screening * Subjects who are unable to complete the symptom diary * Subjects who will need conventional therapy during the course of the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?