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TevaGastrim for Stem Cell Mobilization Sibling Donors

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: NCT01542944
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : April 20, 2016
Information provided by (Responsible Party):
Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE February 19, 2012
First Posted Date  ICMJE March 2, 2012
Last Update Posted Date April 20, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
Mobilisation success rate [ Time Frame: 4 weeks ]
Mobilisation success rate is defined as the mobilisation of a PBSC graft containing >2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach >2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching >5x10 CD34+ cells/kg in ≤ 4 apheresis sessions.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
  • engraftment after transplantation [ Time Frame: 100 days ]
    speed of engraftment is determined by the time until recovery of blood counts after transplantation
  • Donor safety [ Time Frame: 100 days ]
    To determine side effects to the stem cell donor
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 TevaGastrim for Stem Cell Mobilization Sibling Donors
Official Title  ICMJE TevaGastrim for Stem Cell Mobilization of HLA Matched Sibling Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Brief Summary The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells from normal sibling donors for allogeneic stem cell transplantation.
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
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
Intervention  ICMJE Drug: TevaGastrim
TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.
Study Arms  ICMJE Experimental: TevaGastrim
treatment with TevaGastrim for allogeneic stem cell collection
Intervention: Drug: TevaGastrim
Publications * Not Provided

*   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: March 1, 2012)
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. Age between 18 and 70 years.
  2. Normal sibling donor that is HLA matched to a patient with AML or MDS that needs and is eligible for allogeneic stem cell transplantation
  3. Written informed consent.

Exclusion Criteria:

  1. Inability to tolerate PBPC harvest.
  2. Peripheral venous access not possible.
  3. Positive pregnancy test for female donors.
  4. Positive serology for hepatitis C and/or HBSAg, unless negative for antigen PCR.
  5. Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study.
  6. Treatment with other investigational drugs.
  7. Known sensitivity to CHO derived products.
  8. HIV positive.
  9. History of malignant disease or current malignancy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01542944
Other Study ID Numbers  ICMJE SHEBA-11-9090-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 Chaim 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