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Completed

NCT Number: NCT01542944

TevaGastrim for Stem Cell Mobilization Sibling Donors

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.

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Key information

Conditions

Acute Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 70 years.
  • Normal sibling donor that is HLA matched to a patient with AML or MDS that needs and is eligible for allogeneic stem cell transplantation
  • Written informed consent.

Exclusion criteria

  • Inability to tolerate PBPC harvest.
  • Peripheral venous access not possible.
  • Positive pregnancy test for female donors.
  • Positive serology for hepatitis C and/or HBSAg, unless negative for antigen PCR.
  • Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study.
  • Treatment with other investigational drugs.
  • Known sensitivity to CHO derived products.
  • HIV positive.
  • History of malignant disease or current malignancy.

Treatment and study plan

TevaGastrim

Drug

TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 2, 2012
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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