TevaGastrim for Stem Cell Mobilization Sibling Donors

Sheba Medical Center

Status and phase: Completed; Phase 2

Conditions: Myelodysplastic Syndrome; Acute Myeloid Leukemia

Treatments: Drug: TevaGastrim

Study type: Interventional

Funder types: Other

Identifiers

NCT01542944

SHEBA-11-9090-AN-CTIL

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

TevaGastrim

Experimental group

Description:

treatment with TevaGastrim for allogeneic stem cell collection

Treatment:

Drug: TevaGastrim