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TevaGastrim for Stem Cell Mobilization Sibling Donors

This study has been completed.
Information provided by (Responsible Party):
Sheba Medical Center Identifier:
First received: February 19, 2012
Last updated: April 19, 2016
Last verified: April 2016
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 Intervention Phase
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Drug: TevaGastrim
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 24
Study Start Date: February 2012
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01542944

Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center Identifier: NCT01542944     History of Changes
Other Study ID Numbers: SHEBA-11-9090-AN-CTIL
Study First Received: February 19, 2012
Last Updated: April 19, 2016

Keywords provided by Sheba Medical Center:
Acute myeloid leukemia
Myelodysplastic syndrome
Stem Cell Mobilization
Allogeneic Stem Cell Transplantation

Additional relevant MeSH terms:
Leukemia, Myeloid
Myelodysplastic Syndromes
Leukemia, Myeloid, Acute
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions processed this record on April 25, 2017