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

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez (Other)

Overall Status

Unknown status

CT.gov ID

NCT03244930

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin Lymphoma, Hodgkin Myeloma Stem Cell Transplant Complications	Drug: Plerixafor 0.12 mg/kg	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, open-labeled, single-arm studyProspective, open-labeled, single-arm study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 10, 2017

Anticipated Primary Completion Date :

May 10, 2018

Anticipated Study Completion Date :

Jun 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	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. Other Names: mozobil

Arm

Intervention/Treatment

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.

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.

Other Names:

mozobil

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Time to engraftment [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 [5 days]
Rate of patients reaching a peripheral blood precount higher than 20 cells/μL

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Candidates planned for an autologous haematopoietic stem cell transplantation without previous mobilization attempts with chemotherapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
WBC count ≥2.5x109/L.
Absolute neutrophil count ≥1.5x109/L.
Platelet count ≥100x109/L

Exclusion Criteria:

Prior allogeneic or autologous transplantation.
Pregnant women.
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.
Positive serology for hepatitis B or C or HIV.
Left ventricular ejection fraction < 40%
AST ALT >2.5x or Creatinine >2 md/dL

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez", Universidad Autónoma de Nuevo Leon	Monterrey	Nuevo Leon	Mexico	64460

Sponsors and Collaborators

Hospital Universitario Dr. Jose E. Gonzalez

Investigators

Study Director: David Gomez Almaguer, md, Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez"

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Gomez Almaguer, Hematology division chief, Hospital Universitario Dr. Jose E. Gonzalez

ClinicalTrials.gov Identifier:

NCT03244930

Other Study ID Numbers:

HE17-00007

First Posted:

Aug 10, 2017

Last Update Posted:

Aug 10, 2017

Last Verified:

Aug 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Non-Hodgkin

Hodgkin Disease

Plerixafor

Study Results

No Results Posted as of Aug 10, 2017