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

Phase 2

• Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Hodgkin; Myeloma; Stem Cell Transplant Complications
• Interventions: Drug: Plerixafor 0.12 mg/kg

• Registration Number: NCT03244930
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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.

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 Timeline

• Study Start: 2017-05-10
• Status Verified: 2017-08
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-09
• Last Update Submitted: 2017-08-09
• Study First Posted: 2017-08-10
• Last Update Posted: 2017-08-10
• Primary Completion: 2018-05-10
• Study Completion: 2018-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Plerixafor 0.12 mg/kg	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Time to engraftment	100 days	Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl

Trial Locations

Locations (1)

Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez", Universidad Autónoma de Nuevo Leon; 🇲🇽 Monterrey, Nuevo Leon, Mexico