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Lonquek for Autologous Stem Cell Mobilization

NCT ID: NCT02488382

Last Updated: 2017-10-17

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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-07-31

Brief Summary

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The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells for autologous stem cell transplantation in patients with lymphoma and multiple myeloma.

Detailed Description

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Conditions

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Lymphoma Multiple Myeloma

Keywords

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lymphoma multiple myeloma stem cell mobilization autologous stem cell transplantation

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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Lonquek

treatment with Lonquek for autologous stem cell collection

Group Type EXPERIMENTAL

Lonquek

Intervention Type DRUG

Patients will be given a single fixed dose of Lonquek (Teva LTD), 12-mg subcutaneously.

Interventions

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Lonquek

Patients will be given a single fixed dose of Lonquek (Teva LTD), 12-mg subcutaneously.

Intervention Type DRUG

Other Intervention Names

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Lipegfilgrastim

Eligibility Criteria

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Inclusion Criteria

* Patients with confirmed multiple myeloma or Hodgkins or non Hodgkin lymphoma at need of autologous stem cell transplantation.
* Disease must be chemosensitive or stable status to prior therapy before transplant.
* Age between 18 and 65 years inclusive.
* ECOG performance status 0, 1 or 2.
* Written informed consent.
* Adequate birth control in fertile patients.

* Patients with factors predicting poor mobilization including \>3 lines of previous chemotherapy, extensive irradiation, patients that received stem cell toxicity drugs like Melphalan, Fludarabine, \>2 courses of Revlimid, age \>65 years, platelets counts \<100x109/L, WBC\<2.5x109/L or WBC \> 35x109/L.
* Previous autologous stem cell transplantation.
* Inability to tolerate peripheral blood stem cell harvest.
* Peripheral venous access not possible.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 RECRUITING

Countries

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Israel

Central Contacts

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Arnon Nagler, MD

Role: CONTACT

Phone: 972 3 530 5830

Email: [email protected]

Avichai Shimoni, MD

Role: CONTACT

Phone: 9972 3 530 5830

Email: [email protected]

Facility Contacts

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Avichai Shimoni, MD

Role: primary

References

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Danylesko I, Sareli R, Varda-Bloom N, Yerushalmi R, Shem-Tov N, Magen H, Shimoni A, Nagler A. Long-acting granulocyte colony-stimulating factor pegfilgrastim (lipegfilgrastim) for stem cell mobilization in multiple myeloma patients undergoing autologous stem cell transplantation. Int J Hematol. 2021 Sep;114(3):363-372. doi: 10.1007/s12185-021-03177-9. Epub 2021 Jul 2.

Reference Type DERIVED
PMID: 34213732 (View on PubMed)

Other Identifiers

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SHEBA-14-1852-AN-CTIL

Identifier Type: -

Identifier Source: org_study_id