Study Results
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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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2012-02-29
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TevaGastrim
treatment with TevaGastrim for allogeneic stem cell collection
TevaGastrim
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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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
Countries
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Other Identifiers
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SHEBA-11-9090-AN-CTIL
Identifier Type: -
Identifier Source: org_study_id
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