Lonquek for Autologous Stem Cell Mobilization | NCT02488382

Studies
Lonquek for Autologous Stem Cell Mobilization

NCT02488382

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Oct 17, 2017Actual

Enrollment

24Estimated

Phase

Phase 1Phase 2

Conditions

Lymphoma
Multiple Myeloma

Interventions

Lonquek

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

May 20, 2015

First Submission Date that Met QC Criteria

Jul 1, 2015

First Posted Date

Jul 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2017

Last Update Posted Date

Oct 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lonquek	Experimental	treatment with Lonquek for autologous stem cell collection	Drug: Lonquek

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lonquek	Drug	Patients will be given a single fixed dose of Lonquek (Teva LTD), 12-mg subcutaneously.	Lonquek

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Arnon Nagler, MD	Contact	972 3 530 5830		a.nagler@sheba.health.gov.il
Avichai Shimoni, MD	Contact	9972 3 530 5830		ashimoni@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Arnon Nagler, MD	Chaim Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chaim Sheba Medical Center	Recruiting	Tel Litwinsky		52621	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34213732	Derived	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.

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

ID	Term
D008223	Lymphoma
D009101	Multiple Myeloma