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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

Low Dose Plerixafor Plus G-CSF Efficiency in Mobilizing Stem Cells From Lymphoma and Myeloma Patients for Autologous Peripheral Blood Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03244930
• Other study ID #: HE17-00007
• Status: Recruiting
• Phase: Phase 2
• First received: August 7, 2017
• Last updated: August 9, 2017
• Start date: May 10, 2017
• Est. completion date: June 10, 2018

Study information

• Verified date: August 2017
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: Perla Colunga, MD
• Phone: +528110761973
• Email: alrep_rcp[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 10, 2018
• Est. primary completion date: May 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 =2.5x109/L.

4. Absolute neutrophil count =1.5x109/L.

5. Platelet count =100x109/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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Hodgkin
• Lymphoma, Non-Hodgkin
• Myeloma
• Stem Cell Transplant Complications

Intervention

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.

Locations

Country	Name	City	State
Mexico	Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez", Universidad Autónoma de Nuevo Leon	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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 hematopoieti — View Citation

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-stimula — View Citation

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 — View Citation

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 autolog — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harvest of of at least 2 x106 CD34+/kg	percentage of patients with a target yields of at least 2 x 106 CD34+ cells/kg in one single aphaeresis procedure.	5 days
Secondary	Time to engraftment	Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl	100 days
Secondary	Rate of patients reaching a peripheral blood precount higher than 20 cells/µL	Rate of patients reaching a peripheral blood precount higher than 20 cells/µL	5 days