Study on Ruxolitinib Phosphate for Reducing Fatigue in Patients with Chronic Lymphocytic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02131584

Provider View

This clinical trial is testing whether the drug ruxolitinib phosphate can help reduce fatigue in patients with chronic lymphocytic leukemia (CLL). The study aims to see if this medication can also help decrease the size of lymph nodes and lower the number of leukemia cells in the blood.

Patient Parameters

Program Overview

The purpose of this study is to find out if ruxolitinib phosphate can effectively reduce fatigue in patients with chronic lymphocytic leukemia (CLL) who do not currently need cancer treatment. Ruxolitinib phosphate works by blocking a protein called Janus kinase (JAK), which is important for cancer cell growth. This study will also look at whether the drug can help reduce other symptoms and assess the overall disease burden and response.

Description

The main goal of this study is to measure how much ruxolitinib phosphate can reduce fatigue in patients with chronic lymphocytic leukemia (CLL) using a tool called the Brief Fatigue Inventory (BFI). Patients in this study do not need immediate cancer treatment according to specific guidelines.

The study will also look at other symptoms using a questionnaire called the M. D. Anderson Symptom Inventory (MDASI) and evaluate the overall disease burden and response based on established criteria.

Participants will take ruxolitinib phosphate by mouth twice a day, about 12 hours apart, for up to two years, as long as their disease does not worsen and they do not experience unacceptable side effects.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and sign an informed consent document
  • Diagnosed with chronic lymphocytic leukemia (CLL) but not needing treatment according to specific guidelines
  • May have been treated before or not
  • Experiencing fatigue with a score of 2 or higher on a symptom scale
  • Hemoglobin level of 12.0 g/dL or higher at screening
  • Platelet count of at least 75 x 10^9/L at screening
  • Absolute neutrophil count (ANC) of 0.5 x 10^9/L or higher at screening
  • Stopped all CLL treatment drugs at least 30 days before starting the study
  • Performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities

Exclusion Criteria

  • Women who are pregnant or breastfeeding
  • Individuals of childbearing potential not willing to use effective birth control methods during the study and for 30 days after stopping the study drug
  • Recent history of inadequate bone marrow reserve, except for acute blood loss
  • Liver enzyme levels (ALT) more than 2.5 times the upper limit of normal
  • Kidney function (GFR) less than 30 mL/min
  • Active uncontrolled infection or HIV positive
  • History of invasive cancer in the past 2 years, except for certain skin or thyroid cancers
  • Uncontrolled heart disease
  • Taking certain prohibited medications or investigational drugs
  • Previous treatment with JAK inhibitors
  • Active alcohol or drug addiction
  • Any condition that might jeopardize safety or compliance with the study
  • Unknown transfusion history for at least 12 weeks before screening
  • Unable to complete the symptom diary
  • Need for conventional therapy during the study

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.