- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02488382
Lonquek for Autologous Stem Cell Mobilization
October 16, 2017 updated by: Sheba Medical Center
Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arnon Nagler, MD
- Phone Number: 972 3 530 5830
- Email: a.nagler@sheba.health.gov.il
Study Contact Backup
- Name: Avichai Shimoni, MD
- Phone Number: 9972 3 530 5830
- Email: ashimoni@sheba.health.gov.il
Study Locations
-
-
-
Tel-Hashomer, Israel, 52621
- Recruiting
- Chaim Sheba Medical Center
-
Contact:
- Avichai Shimoni, MD
- Phone Number: 972 3 530 5303
- Email: ashimoni@sheba.health.gov.il
-
Principal Investigator:
- Arnon Nagler, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lonquek
treatment with Lonquek for autologous stem cell collection
|
Patients will be given a single fixed dose of Lonquek (Teva LTD), 12-mg subcutaneously.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobilisation success rate
Time Frame: 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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
engraftment after transplantation
Time Frame: 100 days
|
Time until recovery of blood counts after transplantation
|
100 days
|
Safety
Time Frame: 100 days
|
Number of participants with adverse events
|
100 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
July 1, 2020
Study Registration Dates
First Submitted
May 20, 2015
First Submitted That Met QC Criteria
July 1, 2015
First Posted (Estimate)
July 2, 2015
Study Record Updates
Last Update Posted (Actual)
October 17, 2017
Last Update Submitted That Met QC Criteria
October 16, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Lymphoma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- SHEBA-14-1852-AN-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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