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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia

Intervention: Ruxolitinib (Drug); Questionnaire (Behavioral)

Phase: Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Zeev Estrov, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Zeev Estrov, MD, Phone: 713-794-1675

Summary

The goal of this clinical research study is to learn if Jakafi (ruxolitinib) can help to control fatigue and other symptoms in patients with CLL who do not need treatment for the cancer. Researchers also want to learn if ruxolitinib can decrease the size of enlarged lymph nodes and/or lower the number of CLL cells in the blood.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Reduction in Fatigue

Detailed description: Study Drug Administration: If you are found to be eligible to take part in this study, you will take ruxolitinib pills 2 times a day, about 12 hours apart. If you miss a dose, do not take an extra dose. Instead, take your next dose on time. If you vomit a dose within 30 minutes after taking it, you can take an extra dose to make it up for it. If you vomit and more than 30 minutes has passed since you took ruxolitinib, do not take an extra dose. Instead, take your next dose on time. If needed, your doctor may raise or lower your dose of ruxolitinib, based on how the disease is responding to the drug or if you are experiencing severe side effects. Study Visits: At about 2 weeks and then 3 months after your first study drug dose:

- Blood (about 1 teaspoon) will be drawn for cytokine testing.

- You will fill out the symptom questionnaire during your clinic visit.

About every 1-2 months:

- You will have a physical exam.

- Blood (about 1 teaspoon) will be drawn for routine tests.

If it is more convenient, some of the study tests and procedures can be done at your home doctor's office. Length of Treatment: You may receive the study drug for up to 2 years. At that point, you may be allowed to continue taking the study drug for as long as the sponsor provides the drug and the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. This is an investigational study. Ruxolitinib is FDA approved and commercially available for the treatment of myelofibrosis (MF). Giving ruxolitinib to patients with CLL is investigational. The study doctor can explain how the study drug is designed to work. Up to 60 participants will enrolled in this study. All will take part at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Subjects who are able to understand and sign an informed consent document. 2. Subjects 18 years of age or older. 3. Subjects must be diagnosed with CLL and do not meet the IWCLL criteria for treatment. 4. Patients may have been previously treated or previously untreated. 5. Symptomatic patients with a BFI symptom scale of 2 points or greater. 6. Subjects with hemoglobin values at the Screening visit equal to or greater than 12. 0 g/dL. 7. Subjects with a platelet count of at least 75 x10^9/L at the screening visit. 8. Subjects with an absolute neutrophil count (ANC) of equal to or higher than 0. 5 x109/L at the screening visit.

9. Subjects must have discontinued all drugs used to treat CLL no later than Day - 30.

10. Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Exclusion Criteria: 1. Females who are pregnant or are currently breastfeeding. 2. 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) 3. 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. 4. Subjects with inadequate liver or renal function at screening and baseline visits: • Alanine aminotransferase (ALT) > 2. 5x ULN. • Modification of Diet in Renal Disease (MDRD) calculated GFR < 30 mL/min 5. Subjects with active uncontrolled infection or who are 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). 6. 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 PI. 7. Subjects with clinically significant uncontrolled cardiac disease. 8. Subjects being treated concurrently with any prohibited medications, including investigational medication, rifampin, St. John's wort, and potent CYP3A4 inhibitors (excluding ketoconazole) unless continuation of such medications are determined by the investigator to be in the best interest of the patient. 9. Subjects who have previously received JAK inhibitor therapy. 10. Subjects with active alcohol or drug addiction that would interfere with their ability to comply with the study requirements. 11. Subjects with any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol. 12. Subjects who have unknown transfusion history for at least the 12 weeks prior to screening. 13. Subjects who are unable to complete the symptom diary. 14. Subjects who will need conventional therapy during the course of the study.

Locations and Contacts

Zeev Estrov, MD, Phone: 713-794-1675

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: September 2014
Last updated: August 6, 2015

Page last updated: August 23, 2015

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