Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia

NCT02131584 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2013-0044NCI-2014-01465
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 size of lymph nodes and/or lower the number of chronic lymphocytic leukemia cells in the blood.

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (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.

  Baseline to 3 months

Secondary Outcomes (2)

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

  Up to 3 months

• 20% improvement in symptoms

  Up to 3 months

Study Arms (1)

Supportive care (ruxolitinib phosphate)

EXPERIMENTAL

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

Other: Questionnaire Administration; Drug: Ruxolitinib Phosphate

Interventions

Questionnaire Administration OTHER

Ancillary studies

Supportive care (ruxolitinib phosphate)

Ruxolitinib Phosphate DRUG

Given PO

Also known as: INCB-18424 Phosphate, Jakafi

Supportive care (ruxolitinib phosphate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 28089238 DERIVED

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandra Ferrajoli

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 6, 2014
• Study Start: September 2, 2014
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)