NCT02488382

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1 lymphoma

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

May 20, 2015

Last Update Submit

October 16, 2017

Conditions

LymphomaMultiple Myeloma

Keywords

lymphomamultiple myelomastem cell mobilizationautologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Mobilisation success rate

    Mobilisation success rate is defined as the mobilisation of a peripheral blood stem cell graft containing \>2x106 CD34+ cells/kg in ≤ 4 apheresis sessions.

    4 weeks

Secondary Outcomes (2)

  • engraftment after transplantation

    100 days

  • Safety

    100 days

Study Arms (1)

Lonquek

EXPERIMENTAL

treatment with Lonquek for autologous stem cell collection

Drug: Lonquek

Interventions

LonquekDRUG

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

Also known as: Lipegfilgrastim
Lonquek

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34213732DERIVED

MeSH Terms

Conditions

LymphomaMultiple Myeloma

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Study Officials

  • Arnon Nagler, MD

    Chaim Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnon Nagler, MD

CONTACT

972 3 530 5830a.nagler@sheba.health.gov.il

Avichai Shimoni, MD

CONTACT

9972 3 530 5830ashimoni@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

July 2, 2015

Study Start

July 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2020

Last Updated

October 17, 2017

Record last verified: 2017-10

Locations

IL(1)