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

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Unknown; Phase 2

Conditions: Lymphoma, Hodgkin; Stem Cell Transplant Complications; Myeloma; Lymphoma, Non-Hodgkin

Treatments: Drug: Plerixafor 0.12 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT03244930

HE17-00007

Details and patient eligibility

About

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 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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Arm 1

Experimental group

Description:

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.

Treatment:

Drug: Plerixafor 0.12 mg/kg