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

H

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)

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

Trial contacts and locations

1

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Central trial contact

Perla Colunga, MD; Dalila Alvarado, MD

Data sourced from clinicaltrials.gov

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