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Chronic Lymphocytic LeukemiaPhase 2NCT02131584

Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia

A Phase 2 study testing Questionnaire Administration and Ruxolitinib Phosphate in people with Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial studies how well ruxolitinib phosphate works in reducing fatigue in patients with chronic lymphocytic leukemia. Ruxolitinib phosphate may stop the growth of cancer cells by blocking a protein called Janus kinase (JAK) that is needed for cell growth and may also help control fatigue, decrease the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Questionnaire Administration and Ruxolitinib Phosphate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
2 Sep 2014to 30 Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Administration of Jakafi (Ruxolitinib) for Symptom Control of Patients With Chronic Lymphocytic Leukemia (CLL): A Phase II Study

This phase II trial studies how well ruxolitinib phosphate works in reducing fatigue in patients with chronic lymphocytic leukemia. Ruxolitinib phosphate may stop the growth of cancer cells by blocking a protein called Janus kinase (JAK) that is needed for cell growth and may also help control fatigue, decrease the size of lymph nodes and/or lower the number of chronic lymphocytic leukemia cells in the blood.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To estimate the reduction in fatigue as measured by the Brief Fatigue Inventory (BFI) of patients with chronic lymphocytic leukemia (CLL) who do not require anti-neoplastic therapy according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 recommendations.

SECONDARY OBJECTIVE:

  1. To estimate the reduction in other symptoms using the M. D. Anderson Symptom Inventory (MDASI) and to assess disease burden and response by the IWCLL 2008 response criteria.

OUTLINE:

Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) (approximately 12 hours apart) for up to 2 years in the absence of disease progression or unacceptable toxicity.

Being tested
Questionnaire Administration, Ruxolitinib Phosphate
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire AdministrationOther

    Ancillary studies

  • Ruxolitinib PhosphateDrug

    Also called INCB-18424 Phosphate, Jakafi

    Given PO

Study groups in NCT02131584
Study groupRoleWhat they receive
Supportive care (ruxolitinib phosphate)ExperimentalPatients receive ruxolitinib phosphate PO BID (approximately 12 hours apart) for up to 2 years in the absence of disease progression or unacceptable toxicity.
Receives: Other: Questionnaire Administration; Drug: Ruxolitinib Phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fatigue

    As measured by the Brief Fatigue Inventory (BFI) question 3 regarding the worst fatigue in the past 24 hours. Will be analyzed in a continuous fashion.

    Measured: Baseline to 3 months

Secondary outcomes (2)

  1. Proportion of patients with 2 point reductions in the BFI #3 score

    Proportion of patients at 3 months versus at enrollment tabulated.

    Measured: Up to 3 months

  2. 20% improvement in symptoms

    As measured by the M. D. Anderson Symptom Inventory (MDASI).

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2014 (estimated)
  2. Study start2 Sep 2014
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02131584
Sponsor's protocol ID
2013-0044
Other IDs
NCI-2014-01465, 2013-0044
Status last verified
Sep 2026
First submitted
2 May 2014
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Jain P, Keating M, Renner S, Cleeland C, Xuelin H, Gonzalez GN, Harris D, Li P, Liu Z, Veletic I, Rozovski U, Jain N, Thompson P, Bose P, DiNardo C, Ferrajoli A, O'Brien S, Burger J, Wierda W, Verstovsek S, Kantarjian H, Estrov Z. Ruxolitinib for symptom control in patients with chronic lymphocytic leukaemia: a single-group, phase 2 trial. Lancet Haematol. 2017 Feb;4(2):e67-e74. doi: 10.1016/S2352-3026(16)30194-6. Epub 2017 Jan 12.

    PubMed 28089238

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Questionnaire Administration and Ruxolitinib Phosphate in people with Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fatigue (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02131584, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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