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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01542944
Other study ID # SHEBA-11-9090-AN-CTIL
Secondary ID
Status Completed
Phase Phase 2
First received February 19, 2012
Last updated April 19, 2016
Start date February 2012
Est. completion date April 2016

Study information

Verified date April 2016
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Israel Chaim Sheba Medical Center Tel-Hashomer

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks Yes
Secondary engraftment after transplantation speed of engraftment is determined by the time until recovery of blood counts after transplantation 100 days Yes
Secondary Donor safety To determine side effects to the stem cell donor 100 days Yes
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