NCT01542944 is a Phase 2 clinical trial of TevaGastrim in Acute Myeloid Leukemia, sponsored by Sheba Medical Center.

Who is sponsoring NCT01542944?

NCT01542944 is sponsored by Sheba Medical Center.

What drugs are being tested in NCT01542944?

Interventions in NCT01542944: TevaGastrim.

What condition does NCT01542944 study?

NCT01542944 studies Acute Myeloid Leukemia, Myelodysplastic Syndrome.

Is NCT01542944 still recruiting?

NCT01542944 is currently completed. Last updated 19 April 2016.

Last reviewed 2016-04-19 · How we verify

NCT01542944

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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)

Completed Phase 2 Last updated 19 April 2016

What this trial tests

Phase 2 trial testing TevaGastrim in Acute Myeloid Leukemia in 24 participants. Completed in 1 April 2016.

Timeline

1 February 2012

Primary endpoint
1 April 2016

1 April 2016

Quick facts

Lead sponsor	Sheba Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 February 2012
Primary completion	1 April 2016
Estimated completion	1 April 2016
Sites	1 location across Israel

Drugs / interventions tested

TevaGastrim — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →

Sponsor

Sheba Medical Center

Who can join

Adults 18 to 70, any sex, with Acute Myeloid Leukemia or Myelodysplastic Syndrome. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mobilisation success rate
Time frame: 4 weeks
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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Biosimilar Filgrastim (Tevagrastim, XMO2) for Allogeneic Hematopoietic Stem Cell Mobilization and Transplantation in Patients with Acute Myelogenous Leukemia/Myelodysplastic Syndromes.
Danylesko I, Sareli R, Bloom-Varda N, Yerushalmi R, et al · · 2016 · cited 8× · PMID 26343949 · DOI 10.1016/j.bbmt.2015.08.033

Verify or expand the search:

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
NCT06782542 — Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for I · Phase 2 · recruiting
NCT07177079 — High-dose Ascorbate (HDA) in Combination With Standard of Care Azacitidine and Venetoclax in Acute Myeloid Leukemia (AML · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other Sheba Medical Center trials

Trials by the same sponsor.

NCT07401524 — Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage · Phase 4 · not yet recruiting
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NCT07509229 — 9-cis Beta-Carotene-Rich Extract of Dunaliella Alga in Retinitis Pigmentosa Patients · Phase 1, PHASE2 · not yet recruiting
NCT07405723 — Arm Position and Blood Pressure Measurement Accuracy During Pregnancy · NA · recruiting
NCT07474987 — Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01542944 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sheba Medical Center
Last refreshed: 19 April 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01542944.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing