Lonquek for Autologous Stem Cell Mobilization

Phase 1

• Conditions: Lymphoma; Multiple Myeloma
• Interventions: Drug: Lonquek

• Registration Number: NCT02488382
• Lead Sponsor: Sheba Medical Center

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 available

Study Timeline

• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Study Start: 2017-07-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-17
• Primary Completion: 2018-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lonquek	Lonquek	treatment with Lonquek for autologous stem cell collection

Primary Outcome Measures

Name	Time	Method
Mobilisation success rate	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.

Secondary Outcome Measures

Name	Time	Method
Safety	100 days	Number of participants with adverse events
engraftment after transplantation	100 days	Time until recovery of blood counts after transplantation

Trial Locations

Locations (1)

Chaim Sheba Medical Center; 🇮🇱 Tel-Hashomer, Israel