TevaGastrim for Stem Cell Mobilization Sibling Donors

Conditions

Acute Myeloid Leukemia, Myelodysplastic Syndrome

Keywords

Acute myeloid leukemia, Myelodysplastic syndrome, Stem Cell Mobilization, Allogeneic Stem Cell Transplantation

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.

Ivetta Danylesko, Rina Sareli, Nira Bloom-Varda, Ronit Yerushalmi, Noga Shem‐Tov et al. (7 authors)

Biology of Blood and Marrow Transplantation2015-09-0412 citations

10.1016/j.bbmt.2015.08.033

The Use of Tevagrastim (Biosimilar Filgrastim XMO2) for Hematopoietic Stem Cell Mobilization in HLA Matched Sibling Donors for Allogeneic Stem Cell Transplantation to AML/MDS Patients

Ivetta Danylesko, Rina Sareli, Nira Bloom-Varda, Ronit Yerushalmi, Noga Shem‐Tov et al. (8 authors)

Biology of Blood and Marrow Transplantation2014-02-014 citations

10.1016/j.bbmt.2013.12.434

The Use Of Tevagrastim (Biosimilar Filgrastim XMO2) For Hematopoietic Stem Cell Mobilization In HLA Matched Sibling Donors For Allogeneic Stem Cell Transplantation To AML/MDS Patients

Ivetta Danylesko, Rina Sareli, Nira Bloom-Varda, Ronit Yerushalmi, Noga Shem‐Tov et al. (8 authors)

Blood2013-11-152 citations

10.1182/blood.v122.21.3275.3275

Interventions

DRUGTevaGastrim

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

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Mobilisation success rate	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

Measure	Time frame	Description
engraftment after transplantation	100 days	speed of engraftment is determined by the time until recovery of blood counts after transplantation
Donor safety	100 days	To determine side effects to the stem cell donor

Countries

Israel

Outcome results

None listed