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Trial record 2 of 11 for:    Sheba | Chronic Myeloid Leukemia | Israel

Nilotinib Pre and Post Allogeneic Stem Cell Transplantation

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. Identifier: NCT00750659
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):
Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE September 9, 2008
First Posted Date  ICMJE September 10, 2008
Last Update Posted Date April 20, 2016
Study Start Date  ICMJE July 2009
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2008)
Safety [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2008)
response [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Nilotinib Pre and Post Allogeneic Stem Cell Transplantation
Official Title  ICMJE Open-label Trial of Nilotinib in Patients With Advanced (>CP1) Chronic Myeloid Leukemia or Ph+ Acute Lymphatic Leukemia Pre- and Post- Allogeneic Stem Cell Transplantation.
Brief Summary Current therapeutic results in advanced chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL) are rather disappointing. Most of these patients will eventually undergo allogeneic stem cell transplantation. Nilotinib is a novel TKI tyrosine kinase inhibitor with 30 fold more potency than Imatinib. Based on previous preliminary experience the author we rationalize that Nilotinib therapy pre- allogeneic transplantation for patients with advanced CML and Ph+ALL will reduce tumor mass pre- transplant achieving a state of minimal residual disease (MRD) and therefore may improve transplantation outcome without increasing toxicity. In addition it will allow time for improving patient medical condition and for finding an unrelated donor which will enable allogeneic transplantation , and to induce anti tumor effect post PBSC w\o DLI ( donor lymphocyte infusion)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Stem Cell Transplantation
Intervention  ICMJE Drug: Nilotinib
Nilotinib 400 mg po/BID until transplant. Nilotinib 200-400 mg po/BID post transplant in escalated doses.
Study Arms  ICMJE Experimental: 1
Nilotinib treatment
Intervention: Drug: Nilotinib
Publications * Shimoni A, Volchek Y, Koren-Michowitz M, Varda-Bloom N, Somech R, Shem-Tov N, Yerushalmi R, Nagler A. Phase 1/2 study of nilotinib prophylaxis after allogeneic stem cell transplantation in patients with advanced chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. Cancer. 2015 Mar 15;121(6):863-71. doi: 10.1002/cncr.29141. Epub 2014 Nov 11.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2008)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with Ph+ advanced CML (>CR1) or Ph+ALL.
  2. Hematological, Cytogenetic (Ph+) and/or BCR/ABL positive documented at diagnosis of CML or Ph+ALL pre- alloSCT.
  3. Patients age 18-65 years of age.
  4. .Patients must have an HLA compatible donor willing and capable of donating peripheral blood stem cells (first choice) or bone marrow progenitor cells using conventional techniques, and blood lymphocytes if indicated (HLA compatible defined as 5/6 or 6/6 matched related or matched unrelated donor.
  5. Adequate end organ function, defined as the following:

    total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL , creatinine < 1.5 x ULN

  6. Patient must have LVEF>45% prior entry into study.
  7. Patient must have QTc <450 msec at study entry.
  8. Lung diffusion capacity (DLCO>40% predicted)
  9. Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
  10. Written, voluntary informed consent.

Exclusion Criteria:

  1. Patients with CML in first chronic phase
  2. Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
  3. ECOG performance status > 2
  4. Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
  5. Impaired cardiac function including any one of the following:

    • LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by echocardiogram
    • Inability to determine the QT interval on ECG
    • Complete left bundle branch block
    • Long QT syndrome or a known family history of long QT syndrome.
    • Clinically significant resting bradycardia (<50 beats per minute)
    • QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc
    • Myocardial infarction within 12 months prior to starting study
    • Other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension).
  6. Female patients who are pregnant or breast-feeding.
  7. Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
  8. Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
  9. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
  10. Patient had a major surgery within 2 weeks prior to study entry.
  11. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  12. Patients with active CNS disease (patients with history of CNS disease are allowed).
  13. Patients with pleural effusion or ascites
  14. Patients with a history of pancreatitis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00750659
Other Study ID Numbers  ICMJE SHEBA-08-5288-AN-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnon Nagler, MD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP