TevaGastrim for Stem Cell Mobilization Sibling Donors

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sheba Medical Center

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.