Lonquek for Autologous Stem Cell Mobilization

Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02488382

Enrollment

Registered

2015-07-02

Start date

2017-07-01

Completion date

2020-07-31

Last updated

2017-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Multiple Myeloma

Keywords

lymphoma, multiple myeloma, stem cell mobilization, autologous stem cell transplantation

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.

Interventions

DRUGLonquek

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Exclusion criteria

* Lymphoma patients that did not fulfill the inclusion criteria. * 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
engraftment after transplantation	100 days	Time until recovery of blood counts after transplantation
Safety	100 days	Number of participants with adverse events

Countries

Israel

Contacts

Primary ContactArnon Nagler, MD

a.nagler@sheba.health.gov.il972 3 530 5830

Backup ContactAvichai Shimoni, MD

ashimoni@sheba.health.gov.il9972 3 530 5830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026