TevaGastrim for Stem Cell Mobilization Sibling Donors

Sheba Medical Center24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndrome

Interventions

TevaGastrimDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Chaim Sheba Medical Center

Tel Litwinsky, Israel

Outcomes

Primary Outcomes

Mobilisation success rate

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.

Time frame: 4 weeks

Secondary Outcomes

engraftment after transplantation

speed of engraftment is determined by the time until recovery of blood counts after transplantation

Time frame: 100 days

Donor safety

To determine side effects to the stem cell donor

Time frame: 100 days

Data from ClinicalTrials.gov

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