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Trial record 18 of 136 for:    INCB018424

Administration of Jakafi (Ruxolitinib) to Patients With High-Risk Chronic Lymphocytic Leukemia (CLL)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT03041636
First received: February 1, 2017
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
The goal of this clinical research study is to learn if Jakafi (ruxolitinib) can delay, lower the amount of therapy you may need in the future, or possibly eliminate the need for future therapy in recently diagnosed CLL patients.

Condition Intervention Phase
Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic Other Diseases of Blood and Blood-Forming Organs Chronic Lymphocytic Leukemia Drug: Ruxolitinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Administration of Jakafi (Ruxolitinib) to Patients With Previously Untreated High-Chronic Lymphocytic Leukemia (CLL): A Phase II Clinical Trial

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Clinical Response of Jakafi (Ruxolitinib) to Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) [ Time Frame: Baseline to 6 months after initiation of therapy ]
    Response assessed in accordance with the IWCLL guidelines by CT scan and bone marrow aspiration/biopsy.


Estimated Enrollment: 40
Actual Study Start Date: March 8, 2017
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib
Participants receive Ruxolitinib pills by mouth 2 times each day for up to 3 years.
Drug: Ruxolitinib
Ruxolitinib administered twice daily (bid), approximately 12 hours apart. Starting dose 20 mg twice a day for patients with a platelet count of greater than or equal to 200 x10^9/L (dose level 1) and 15 mg twice a day for patients with a platelet count of greater than or equal to 100 x 10^9/L and less than or equal to 200 x 10^9/L (dose level -1).
Other Names:
  • Jakafi
  • INCB018424
  • INC424

Detailed Description:

All study visits will take place at MD Anderson. If it is more convenient for participant, participant may have participant's physical exams and routine blood draws completed at a local lab or doctor's office. The results of the tests/procedures will be sent to the study doctor for review. This option will be discussed with participant. Otherwise, participant will have these done during the study visits at MD Anderson.

Before participant starts taking ruxolitinib:

  • Blood (about 2 teaspoons) will be drawn for cytokine testing and for a special kind of testing that tells researchers if there are changes in the pathways that helps CLL cells grow. This is called B-cell receptor testing. Cytokines are proteins that may affect the immune system.
  • Participant will have a CT scan to check the status of the disease.
  • Participant will complete 2 questionnaires about participant's symptoms. This should take about 10 minutes to complete.
  • If participant can become pregnant, blood (about 1 teaspoon) and/or urine will be collected for a pregnancy test.

Every 1-2 months and every time participant comes to MD Anderson as part of participant's routine care:

  • Participant will have a physical exam.
  • Blood (2 teaspoons) will be drawn for routine tests. If needed, this blood draw may be repeated every 2-4 weeks.

At about 3 months after participant starts treatment:

  • Blood (about 2 teaspoons) will be drawn for cytokine testing and for B-cell receptor testing.
  • Participant will complete 2 questionnaires about participant's symptoms. This should take about 10 minutes to complete.

About 6-8 months after participant starts treatment:

  • Participant will have a physical exam.
  • Participant will have a bone marrow aspiration to check the status of the disease. To collect a bone marrow aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
  • Participant will have a CT scan.

Follow-Up:

  • About 30 days after participant's last dose of ruxolitinib, blood (abut 2 teaspoons) will be drawn for routine tests.
  • At Day 30 Follow-Up: If participant can become pregnant, blood (about 1 teaspoon) and/or urine will be collected for a pregnancy test.

Participant will have a CT scan.

This is an investigational study. Ruxolitinib is FDA approved and commercially available for the treatment of myelofibrosis (MF). It is considered investigational to use ruxolitinib to treat CLL. The study doctor can explain how the study drug is designed to work.

Up to 40 participants will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (Hallek et al., 2008).
  4. Patients should be previously untreated
  5. Patients whose expected time to CLL treatment, according to our nomogram posted on the leukemia protocol priority list, is two years of less.
  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 100 x10^9 at the screening visit.
  8. Subjects with an absolute neutrophil count (ANC) of equal to or higher than 0.5 x10^9 at the screening visit.
  9. Subject who are willing to undergo a bone marrow aspiration and biopsy and CT scan for disease burden assessment.
  10. Patient who are capable to return to MDACC for follow-up
  11. Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  12. Patient must be capable of swallowing the Ruxolitinib capsules (tablets).

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. A) 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. B) 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: a) Double barrier methods; b) Condom with spermicide in conjunction with use of an intrauterine device (IUD); c) Condom with spermicide in conjunction with use of a diaphragm; d) Oral, injectable, or implanted contraceptives; e) 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: A) Alanine aminotransferase (ALT) > 2.5x ULN. B) 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 a history of or a current malignancy except for treated basal or squamous carcinomas of the skin completely resected.
  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. Refer to protocol section 2.2.12 for more details.
  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.
  13. Patients who cannot comply with the study requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03041636

Contacts
Contact: Zeev Estrov, MD 713-794-1675 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Incyte Corporation
Investigators
Principal Investigator: Zeev Estrov, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03041636     History of Changes
Other Study ID Numbers: 2015-0570
Study First Received: February 1, 2017
Last Updated: April 19, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic
Other Diseases of Blood and Blood-Forming Organs
Chronic Lymphocytic Leukemia
CLL
Ruxolitinib
Jakafi
INCB018424

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms
Hematologic Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on June 22, 2017