Status:
UNKNOWN
Low Dose Plerixafor Plus G-CSF in Mobilizing Stem Cells for Autologous Peripheral Blood Transplantation
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Conditions:
Lymphoma, Non-Hodgkin
Lymphoma, Hodgkin
Eligibility:
All Genders
Phase:
PHASE2
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...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03244930
Start Date
May 10 2017
End Date
June 10 2018
Last Update
August 10 2017
Active Locations (1)
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1
Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez", Universidad Autónoma de Nuevo Leon
Monterrey, Nuevo León, Mexico, 64460