TevaGastrim for Stem Cell Mobilization Sibling Donors

NCT ID: NCT01542944

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TevaGastrim

treatment with TevaGastrim for allogeneic stem cell collection

Group Type EXPERIMENTAL

TevaGastrim

Intervention Type DRUG

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

Interventions

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TevaGastrim

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnon Nagler, MD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center

Locations

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Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-11-9090-AN-CTIL

Identifier Type: -

Identifier Source: org_study_id

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