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Lonquek for Autologous Stem Cell Mobilization

Primary Purpose

Lymphoma, Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Lonquek
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring lymphoma, multiple myeloma, stem cell mobilization, autologous stem cell transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chaim Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lonquek

Arm Description

treatment with Lonquek for autologous stem cell collection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

engraftment after transplantation
Time until recovery of blood counts after transplantation
Safety
Number of participants with adverse events

Full Information

First Posted
May 20, 2015
Last Updated
October 16, 2017
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02488382
Brief Title
Lonquek for Autologous Stem Cell Mobilization
Official Title
Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Multiple Myeloma
Keywords
lymphoma, multiple myeloma, stem cell mobilization, autologous stem cell transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lonquek
Arm Type
Experimental
Arm Description
treatment with Lonquek for autologous stem cell collection
Intervention Type
Drug
Intervention Name(s)
Lonquek
Other Intervention Name(s)
Lipegfilgrastim
Intervention Description
Patients will be given a single fixed dose of Lonquek (Teva LTD), 12-mg subcutaneously.
Primary Outcome Measure Information:
Title
Mobilisation success rate
Description
Mobilisation success rate is defined as the mobilisation of a peripheral blood stem cell graft containing >2x106 CD34+ cells/kg in ≤ 4 apheresis sessions.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
engraftment after transplantation
Description
Time until recovery of blood counts after transplantation
Time Frame
100 days
Title
Safety
Description
Number of participants with adverse events
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnon Nagler, MD
Phone
972 3 530 5830
Email
a.nagler@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Avichai Shimoni, MD
Phone
9972 3 530 5830
Email
ashimoni@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnon Nagler, MD
Organizational Affiliation
Chaim Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avichai Shimoni, MD
Phone
972 3 530 5303
Email
ashimoni@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Arnon Nagler, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34213732
Citation
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.
Results Reference
derived

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Lonquek for Autologous Stem Cell Mobilization

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