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Phase l/II Study of Ruxolitinib for Acute Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01251965
Recruitment Status : Terminated (Study was stopped by the principal investigator due to nonsatisfactory clinical benefit even in patients treated at the highest dose (200 mg ).)
First Posted : December 2, 2010
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of ruxolitinib that can be given to patients with acute leukemia and to learn if the study drug can help control the disease. The safety of the drug will also be studied.

Condition or disease Intervention/treatment Phase
Leukemia Drug: Ruxolitinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Phase I is a standard 3+3 design and will be used to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD), and no formal evaluation of efficacy (response rate will be implemented. Patients in Phase I part who were treated at the MTD will be included toward patients assessed for response in the phase II stage.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study to Determine the Safety and Efficacy of Ruxolitinib, a JAK1/JAK2 Inhibitor, in Subjects With Relapsed or Refractory Acute Leukemia
Study Start Date : December 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012


Arm Intervention/treatment
Experimental: Ruxolitinib 50 mg BID
Phase I - Starting dose of Ruxolitinib 50 mg by mouth twice a day for 28 day cycle.
Drug: Ruxolitinib

Phase I - Starting dose of 50 mg by mouth twice a day for 28 day cycle.

Phase II - MTD reached in Phase I.

Other Names:
  • Jakafi
  • INCBO18424
  • INC424

Experimental: Ruxolitinib 100 mg BID
Phase I dose of Ruxolitinib 100 mg by mouth twice a day for 28 day cycle.
Drug: Ruxolitinib

Phase I - Starting dose of 50 mg by mouth twice a day for 28 day cycle.

Phase II - MTD reached in Phase I.

Other Names:
  • Jakafi
  • INCBO18424
  • INC424

Experimental: Ruxolitinib 200 mg BID
Phase I dose of Ruxolitinib 200 mg by mouth twice a day for 28 day cycle.
Drug: Ruxolitinib

Phase I - Starting dose of 50 mg by mouth twice a day for 28 day cycle.

Phase II - MTD reached in Phase I.

Other Names:
  • Jakafi
  • INCBO18424
  • INC424




Primary Outcome Measures :
  1. Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: End of first 28 day cycle for toxicity ]
    MTD defined as highest dose level at which no more than one out of six subject experiences dose limiting toxicity (DLT) during first cycle (28 days) of therapy. A non-hematologic DLT defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to Common Toxicity Criteria for Adverse Effects (CTCAE) criteria) assessed as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during first 28 days on study. Participants who received at least 80% of the originally assigned doses in the first cycle were evaluable for DLT assessment of each cohort.

  2. Maximum Tolerated Dose (MTD) of Ruxolitinib [ Time Frame: End of first 28 day cycle ]
    The MTD is defined as the highest dose level at which no more than one out of six subject experiences DLT during the first cycle (28 days) of therapy.


Secondary Outcome Measures :
  1. Participants With a Response [ Time Frame: Up to 1 year ]
    Response is defined as complete remission (CR) + complete remission with incomplete blood count (CRi) + Hematologic improvement (HI). Response was to be assessed for participants who were evaluated for the Phase II portion of this study. CR is absolute neutrophil count (ANC) >/= 1x109/L and platelet count >/= 100x109/L, absence of leukemia blast cells, normal marrow differential, and complete resolution of extramedullary disease. CRi is CR but platelets are < 100x109/L or ANC is <1x109/L. HI is described by the number of individual, positively affected cell lines without the use of growth factors and/or transfusions (lasting at least 4 weeks).



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be >14 years of age
  2. Must be diagnosed with refractory or relapsed AML or ALL.
  3. Must have adequate organ function as demonstrated by the following: o Alanine Aminotransferase (ALT) (SGOT) and/or Aspartate Aminotransferase (AST) (SGPT) equal to or less than 1.5x upper limit of normal o Serum creatinine equal to or less than 2.5 mg/dL
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
  5. At least 2 weeks from prior leukemia-directed treatment to starting treatment drug (except for hydroxyurea, which is allowed if clinically indicated but should be stopped after 2 weeks of receiving study drug, and glucocorticoids, which are allowed but should be stopped upon starting treatment drug).
  6. Treatment-related toxicities from prior therapies must have resolved to Grade equal to or less than 1 (except for peripheral neuropathy, which should resolve to grade equal to or less than 2)
  7. No active malignancies with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
  8. Females of childbearing potential (FCBP)(A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) must have negative pregnancy test. FCBP and males participating in the study must agree to use a reliable form of contraception or to practice complete abstinence from heterosexual intercourse while participating in the study and for at least 28 days after discontinuation from the study. If pregnancy or a positive pregnancy test does occur in a study subject, treatment with the study drug must be immediately discontinued.

Exclusion Criteria:

  1. Known positive status for HIV, or known active hepatitis A, B, or C infection.
  2. Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  3. Pregnant or lactating females.
  4. Acute promyelocytic leukemia
  5. Concurrent use of strong inducers or strong inhibitors of cytochrome P450 3A4 (CYP3A4). Strong inducers are rifampin and St. John's Worth. Strong inhibitors are HIV-antivirals, clarythromycin, itraconazole, ketoconazole, nefazodone, and telithromycin.
  6. Participating in any other research trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251965


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Incyte Corporation
Investigators
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Principal Investigator: Srdan Verstovsek, MD M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01251965    
Other Study ID Numbers: 2010-0450
NCI-2011-02439 ( Registry Identifier: NCI CTRP )
First Posted: December 2, 2010    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019
Last Verified: September 2019
Keywords provided by M.D. Anderson Cancer Center:
Relapsed Acute Leukemia
Acute myeloid leukemia
AML
Acute lymphocytic leukemia
ALL
Ruxolitinib
Jakafi
INC424
INCB018424
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms