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TevaGastrim for Stem Cell Mobilization Sibling Donors

This study is currently recruiting participants.
Verified December 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01542944
First received: February 19, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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: Endpoint Classification: Bio-equivalence Study
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:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Mobilisation success rate [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    speed of engraftment is determined by the time until recovery of blood counts after transplantation

  • Donor safety [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
    To determine side effects to the stem cell donor


Estimated Enrollment: 24
Study Start Date: February 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542944

Contacts
Contact: Arnon Nagler, MD 972 3 530 5830 a.nagler@sheba.health.gov.il
Contact: Avichai Shimoni, MD 972 3 530 5303 ashimoni@sheba.health.gov

Locations
Israel
Chaim Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 52621
Contact: Arnon Nagler, MD     972 3 530 5830     a.nagler@sheba.health.gov.il    
Contact: Avichai Shimoni, MD     972 3 530 5303     ashimoni@sheba.health.gov.il    
Principal Investigator: Avichai Shimoni, MD            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Arnon Nagler, MD Chaim Sheba Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01542944     History of Changes
Other Study ID Numbers: SHEBA-11-9090-AN-CTIL
Study First Received: February 19, 2012
Last Updated: December 3, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
 Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on May 16, 2013