TevaGastrim for Stem Cell Mobilization Sibling Donors - Full Text View

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:	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:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Myelodysplastic Syndromes

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes

U.S. FDA Resources

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.

Eligibility


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

Criteria

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.

Contacts and Locations

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, see Learn About Clinical Studies.

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

Locations


Israel
Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621

Sponsors and Collaborators

Sheba Medical Center

Investigators


Principal Investigator:	Arnon Nagler, MD	Chaim Sheba Medical Center

More Information


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:	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:


Syndrome Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Preleukemia Disease	Pathologic Processes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions

ClinicalTrials.gov processed this record on July 21, 2017