Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin, Myeloma, Stem Cell Transplant Complications
Conditions
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.
Interventions
DRUGPlerixafor 0.12 mg/kg
Subcutaneously G-CSF 10 mg/kg for 4 days. At day four SC plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of aphaeresis.
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, open-labeled, single-arm study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to engraftment | 100 days | Engraftment defined as 3 consecutive days of neutrophil counts higher than 0.5 x 103/mcl |
| 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 |
Countries
Mexico
Contacts
Primary ContactPerla Colunga, MD
Backup ContactDalila Alvarado, MD
Outcome results
None listed