NCT01542944

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

4.2 years

First QC Date

February 19, 2012

Last Update Submit

April 19, 2016

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Keywords

Acute myeloid leukemiaMyelodysplastic syndromeStem Cell MobilizationAllogeneic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • engraftment after transplantation

    100 days

  • Donor safety

    100 days

Study Arms (1)

TevaGastrim

EXPERIMENTAL

treatment with TevaGastrim for allogeneic stem cell collection

Drug: TevaGastrim

Interventions

TevaGastrimDRUG

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

TevaGastrim

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 years.
  • Normal sibling donor that is HLA matched to a patient with AML or MDS that needs and is eligible for allogeneic stem cell transplantation
  • Written informed consent.

You may not qualify if:

  • Inability to tolerate PBPC harvest.
  • Peripheral venous access not possible.
  • Positive pregnancy test for female donors.
  • Positive serology for hepatitis C and/or HBSAg, unless negative for antigen PCR.
  • Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study.
  • Treatment with other investigational drugs.
  • Known sensitivity to CHO derived products.
  • HIV positive.
  • History of malignant disease or current malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Study Officials

  • Arnon Nagler, MD

    Chaim Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2012

First Posted

March 2, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

IL(1)