Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Low Dose Plerixafor Plus G-CSF Efficiency in Mobilizing Stem Cells From Lymphoma and Myeloma Patients for Autologous Peripheral Blood Transplantation
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 10, 2018 |
Est. primary completion date | May 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Servicio de Hematología Hospital Universitario "Dr. José Eleuterio Gonzalez", Universidad Autónoma de Nuevo Leon | Monterrey | Nuevo Leon |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Dr. Jose E. Gonzalez |
Mexico,
Brave M, Farrell A, Ching Lin S, Ocheltree T, Pope Miksinski S, Lee SL, Saber H, Fourie J, Tornoe C, Booth B, Yuan W, He K, Justice R, Pazdur R. FDA review summary: Mozobil in combination with granulocyte colony-stimulating factor to mobilize hematopoieti — View Citation
DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, Nademanee A, McCarty J, Bridger G, Calandra G; 3101 Investigators. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimula — View Citation
Flomenberg N, Comenzo RL, Badel K, Calandra G. Plerixafor (Mozobil) alone to mobilize hematopoietic stem cells from multiple myeloma patients for autologous transplantation. Biol Blood Marrow Transplant. 2010 May;16(5):695-700. doi: 10.1016/j.bbmt.2009.12 — View Citation
Haverkos BM, Huang Y, Elder P, O'Donnell L, Scholl D, Whittaker B, Vasu S, Penza S, Andritsos LA, Devine SM, Jaglowski SM. A single center's experience using four different front line mobilization strategies in lymphoma patients planned to undergo autolog — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Harvest of of at least 2 x106 CD34+/kg | percentage of patients with a target yields of at least 2 x 106 CD34+ cells/kg in one single aphaeresis procedure. | 5 days | |
Secondary | Time to engraftment | Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl | 100 days | |
Secondary | Rate of patients reaching a peripheral blood precount higher than 20 cells/µL | Rate of patients reaching a peripheral blood precount higher than 20 cells/µL | 5 days |
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