Low Dose Plerixafor Plus G-CSF in Mobilizing Stem Cells for Autologous Peripheral Blood Transplantation

Overview

Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. We want to demonstrate that half of the commonly prescribed dose can be safely administered once as a single dose in first attempt leading to apheresis yields of >2 x 106 CD34+ cells/kg body weight.

Full Title of Study: “Low Dose Plerixafor Plus G-CSF Efficiency in Mobilizing Stem Cells From Lymphoma and Myeloma Patients for Autologous Peripheral Blood Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 10, 2018

Detailed Description

Plerixafor, is added to mobilizing chemotherapy and G-CSF to overcome poor stem cell mobilization. Consecutive patients in autologous transplant protocol will receive mobilization consisted of daily subcutaneously G-CSF 10 mg/kg for 4 days and plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of apheresis. HSC collection was performed with a Cobe Spectra® or Spectra Optia® apheresis system. The planned target blood volume to be processed will be 4-fold total blood volume calculated according to patients' weight and size. Peripheral blood CD34+ counts will be analyzed using flow cytometry. For each ASCT, we aimed for target yields of at least 2 x 106 CD34+cells/kg. Toxicities and engraftment will be documented.

Interventions

  • Drug: Plerixafor 0.12 mg/kg
    • Subcutaneously G-CSF 10 mg/kg for 4 days. At day four SC plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of aphaeresis.

Arms, Groups and Cohorts

  • Experimental: Arm 1
    • Plerixafor 0.12 mg/kg SC will be administered in the evening, 11 hours prior to initiation of apheresis. G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.

Clinical Trial Outcome Measures

Primary Measures

  • Harvest of of at least 2 x106 CD34+/kg
    • Time Frame: 5 days
    • percentage of patients with a target yields of at least 2 x 106 CD34+ cells/kg in one single aphaeresis procedure.

Secondary Measures

  • Time to engraftment
    • Time Frame: 100 days
    • Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl
  • Rate of patients reaching a peripheral blood precount higher than 20 cells/μL
    • Time Frame: 5 days
    • Rate of patients reaching a peripheral blood precount higher than 20 cells/μL

Participating in This Clinical Trial

Inclusion Criteria

1. Candidates planned for an autologous haematopoietic stem cell transplantation without previous mobilization attempts with chemotherapy. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 3. WBC count ≥2.5×109/L. 4. Absolute neutrophil count ≥1.5×109/L. 5. Platelet count ≥100×109/L Exclusion Criteria:

1. Prior allogeneic or autologous transplantation. 2. Pregnant women. 3. Acute infection (febrile, i.e. temperature > 38C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF. 4. Positive serology for hepatitis B or C or HIV. 5. Left ventricular ejection fraction < 40% 6. AST ALT >2.5x or Creatinine >2 md/dL

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitario Dr. Jose E. Gonzalez
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Gomez Almaguer, Hematology division chief – Hospital Universitario Dr. Jose E. Gonzalez
  • Overall Official(s)
    • David Gomez Almaguer, md, Study Director, Servicio de Hematología Hospital Universitario “Dr. José Eleuterio Gonzalez”
  • Overall Contact(s)
    • Perla Colunga, MD, +528110761973, alrep_rcp@hotmail.com

Citations Reporting on Results

DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol. 2009 Oct 1;27(28):4767-73. doi: 10.1200/JCO.2008.20.7209. Epub 2009 Aug 31.

Flomenberg N, Comenzo RL, Badel K, Calandra G. Plerixafor (Mozobil) alone to mobilize hematopoietic stem cells from multiple myeloma patients for autologous transplantation. Biol Blood Marrow Transplant. 2010 May;16(5):695-700. doi: 10.1016/j.bbmt.2009.12.538. Epub 2010 Jan 11.

Brave M, Farrell A, Ching Lin S, Ocheltree T, Pope Miksinski S, Lee SL, Saber H, Fourie J, Tornoe C, Booth B, Yuan W, He K, Justice R, Pazdur R. FDA review summary: Mozobil in combination with granulocyte colony-stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation. Oncology. 2010;78(3-4):282-8. doi: 10.1159/000315736. Epub 2010 Jun 8.

Haverkos BM, Huang Y, Elder P, O'Donnell L, Scholl D, Whittaker B, Vasu S, Penza S, Andritsos LA, Devine SM, Jaglowski SM. A single center's experience using four different front line mobilization strategies in lymphoma patients planned to undergo autologous hematopoietic cell transplantation. Bone Marrow Transplant. 2017 Apr;52(4):561-566. doi: 10.1038/bmt.2016.304. Epub 2017 Jan 9.

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