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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

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Drug: TevaGastrim Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : February 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: TevaGastrim
treatment with TevaGastrim for allogeneic stem cell collection
Drug: TevaGastrim
TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. engraftment after transplantation [ Time Frame: 100 days ]
    speed of engraftment is determined by the time until recovery of blood counts after transplantation

  2. Donor safety [ Time Frame: 100 days ]
    To determine side effects to the stem cell donor

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT01542944

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Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center
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Responsible Party: Sheba Medical Center Identifier: NCT01542944    
Other Study ID Numbers: SHEBA-11-9090-AN-CTIL
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Keywords provided by Sheba Medical Center:
Acute myeloid leukemia
Myelodysplastic syndrome
Stem Cell Mobilization
Allogeneic Stem Cell Transplantation
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions