Clinical trial · Interventional
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
NCT02488382CI-TRIAL-00029936unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lonquek | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lonquek
- description
- treatment with Lonquek for autologous stem cell collection
- interventionNames
- Drug: Lonquek
Primary outcomes (1)
- measure
- Mobilisation success rate
- timeFrame
- 4 weeks
- 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.
Secondary outcomes (2)
- measure
- engraftment after transplantation
- timeFrame
- 100 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDanylesko 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. PMID 34213732