LymphomaPhase 1/2NCT02488382
Lonquek for Autologous Stem Cell Mobilization
A Phase 1/2 study testing Lonquek in people with Lymphoma and Multiple Myeloma, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, Multiple Myeloma
- What is being tested?
- Lonquek
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2017to Jul 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Chaim Sheba Medical Center
Tel HaShomer, 52621
Avichai Shimoni, MD, 972 3 530 5303, ashimoni@sheba.health.gov.il
Arnon Nagler, MD
About this study
Official title: 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.
- Conditions
- Lymphoma, Multiple Myeloma
- Being tested
- Lonquek
- Keywords
- lymphoma, multiple myeloma, stem cell mobilization, autologous stem cell transplantation
- Medical subject headings
- Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LonquekDrug
Also called Lipegfilgrastim
Patients will be given a single fixed dose of Lonquek (Teva LTD), 12-mg subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Lonquek | Experimental | treatment with Lonquek for autologous stem cell collection Receives: Drug: Lonquek |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
engraftment after transplantation
Time until recovery of blood counts after transplantation
Measured: 100 days
Safety
Number of participants with adverse events
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start1 Jul 2017
- Primary completionJul 2018 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arnon Nagler, MD, Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488382
- Sponsor's protocol ID
- SHEBA-14-1852-AN-CTIL
- Status last verified
- Oct 2017
- First submitted
- 20 May 2015
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34213732
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma
- ClinicalTrials.gov ID
- NCT02488382
- Acronym / sponsor ID
- SHEBA-14-1852-AN-CTIL
- Conditions
- Lymphoma, Multiple Myeloma
- Keywords
- lymphoma, multiple myeloma, stem cell mobilization, autologous stem cell transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lonquek | Experimental | Drug: Lonquektreatment with Lonquek for autologous stem cell collection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LonquekAlso: LipegfilgrastimPatients will be given a single fixed dose of Lonquek (Teva LTD), 12-mg subcutaneously. | Drug | Lonquek |
Primary outcome
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.
2 secondary outcomes
engraftment after transplantation
Time frame: 100 days
Safety
Time frame: 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Derived from this study: PubMed 34213732Danylesko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnon Nagler, MD principal investigator
Chaim Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lonquek in people with Lymphoma and Multiple Myeloma, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnon Nagler, MD (972 3 530 5830, a.nagler@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobilisation success rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.