TevaGastrim for Stem Cell Mobilization Sibling Donors

Acute Myeloid Leukemia Clinical Trial

Official title:

TevaGastrim for Stem Cell Mobilization of HLA Matched Sibling Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542944
• Other study ID #: SHEBA-11-9090-AN-CTIL
• 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

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