Lonquek for Autologous Stem Cell Mobilization

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheba Medical Center

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.