Healthy Donors (Allogeneic Stem Cell Transplant)

  • Growth factor: GCSF 10µg/kg/day (same dose for adults and children).
  • Informed consent and counselling of a healthy donor must be done by a healthcare professional who is not directly involved in the care of the recipient of the donation.
  • Mandatory microbiology screening tests must be carried out for all donors (table below).
  • Healthy donors should be mobilised with non-biosimilars only.
  • Maximal blood volume 24L collected over 1-2 days.
  • CD34+ check: start on D4
  • Apheresis should not be performed when CD34+ cell count <5/µL.
  • Start apheresis when peripheral blood CD34+ cell count >10/µL.
  • Target collection: minimum 2 x 106 CD34+ cells/kg.
    • Higher doses result in faster engraftment, reduced TRM and possibly reduced relapse risk.
    • No benefit beyond a certain threshold (8 – 9.5 x 106 CD34+ cells/kg), likely increased risk of chronic GVHD.
    • Target of 4 – 5 x 106 CD34+ cells/kg probably reasonable.
  • Most cell separators default to two blood volumes.
  • Access: peripheral venous access is acceptable if adequate flow rates can be achieved. Otherwise, central line placement is required.
  • Safety: unrelated donors should not undergo leukapheresis for more than 2 days.
    • There is a risk of thrombocytopaenia due to the inability to completely separate platelets from the target cell layer.
    • The safety of continuing leukapheresis must be reviewed if plt <100×109/L.
  • Splenic rupture risk (general practice, not evidence-based):
    • Withhold GCSF when WBC >100×109/L.
    • Withhold plerixafor when WBC >75×109/L.
  • Other risks of apheresis:
    • Citrate toxicity: hypocalcaemia and low magnesium, with risk of neurological symptoms and arrhythmias.
    • Thrombocytopaenia from platelet loss in the collected fraction.
    • Vasovagal reactions (ACE inhibitors increase this risk for all apheresis procedures, hence all patients on an ACE inhibitor should omit it the  day of the apheresis procedure).
    • Vascular access insertion risks (if non-tunneled catheter required).
    • Blood component transfusion risks.
  • Donor lymphocyte infusion
    • These are therapeutic T cells from the original donor, which can be used to treat mixed chimerism or minimal residual disease following allogeneic SCT.
    • Collection is via a standard mononuclear clear cell collection procedure, using two or three blood volumes.

Autologous Stem Cell Transplant

  • Growth factor: GCSF 10µg/kg/day or pegfilgrastim 12mg single SC dose.
  • Chemotherapy + growth factor: GCSF 5-10µg/kg/day or pegfilgrastim 12mg single SC dose, start leukapheresis when peripheral blood CD34+ cell count adequate.
  • In the absence of specific protocol-driven chemotherapy, mobilisation with cyclophosphamide or etoposide results in higher collection yields and fewer aphersis  days than growth factor alone.
  • CD34+ check:
    • Growth factor alone: start on D4
    • Chemotherapy + growth factor: start on D8-10 of chemotherapy (peak is usually protocol specific, however)
    • Growth factor + plerixafor: start on D4 
  • Start apheresis when peripheral blood CD34+ cell count >5-20/µL (locally in NUH, we start at 10/µL).
    • UK recommendation: start collection when peripheral blood CD34+ cell count >10/µL.
  • Target collection: minimum 2 x 106 CD34+ cells/kg, optimal number > 5 x 106 CD34+ cells/kg.
    • Super mobilisers (>8 x 106 CD34+ cells/kg) associated with faster haematopoietic recovery, more robust long-term platelet recovery and improved overall survival.
  • Apheresis volumes range from standard lower-volume (10-15L, 2-3 blood volumes based on a blood volume calculation of 70ml/kg) procedures to large volume procedures (15-30L, 3-6 blood volumes).
    • Large volume collection (at least 3 blood volumes) is associated with increased CD34+ yields, and should be considered for poor mobilisers (CD34+ <20/µL).
    • However, the larger the collection volume, the larger the risk of apheresis:
      • Citrate toxicity: hypocalcaemia and low magnesium, with risk of neurological symptoms and arrhythmias.
      • Thrombocytopaenia from platelet loss in the collected fraction.
      • Coagulopathy from dilution of coagulation factors.
    • Extending aphersis beyond 4 days is rarely successful.
  • Factors which predict poor mobilisation:
    • Age >60
    • Diagnosis of non-Hodgkin lymphoma
    • Multiple prior lines of chemotherapy
    • Prior exposure to alkylating agents
    • Prior exposure to purine analogues
    • Prior exposure to radiotherapy
    • Prior exposure to lenalidomide
    • Platelet count <100×109/L
    • Low prer-apheresis CD34+ cell count
    • Poor CD34+ cell count (<1×106/kg) on the first day of collection
    • Previous mobilisation failure
  • Potential rescue therapy for poor mobilisers:
    • Increase GCSF dose to 20-30µg/kg/day if not ready for collection by D12-13.
    • D12 or 13 rescue dose of plerixafor.
  • Splenic rupture risk (general practice, not evidence-based):
    • Withhold GCSF when WBC >100×109/L.
    • Withhold plerixafor when WBC >75×109/L.
  • Monitoring (pre- and post-procedure):
    • Electrolytes
    • Coagulation profile
    • FBC
      • Transfusions should be carried out before or after apheresis, not during the procedure.

Plerixafor

  • Up to 30% of patients fail to mobilise with GCSF+chemotherapy alone. 
  • Failure rates for second mobilisation attempts are in excess of 70%.
  • Plerixafor is a CXCR4 antagonist, which results in mobilisation of CD34+ stem cells into the peripheral blood.
  • European licensing: in combination with GCSF to enhance mobilisation in lymphoma / myeloma patients who mobilise poorly.
  • Strategies for plerixafor use:
    • Delayed remobilisation: use after a prior failed mobilisation.
      • Requires re-scheduling of ASCT and waiting 4 weeks for marrow recovery.
    • Preemptive use (UK recommendation): in the course of a mobilisation episode to improve harvest results when a standard mobilisation is predicted to fail (“rescue” or “just-in-time” use). 
    • Upfront: plerixafor in combination with GCSF for all patients.
  • Delayed remobilisation: G-CSF 10µ/kg/day for 4 days, then plerixafor, GCSF+plerixafor can be continued daily with an aphersis session after each dose of plerixafor, up to a maximum of 7 days (60% NHL, 71% myeloma, 77% Hodgkin lymphoma achieved target cell dose of 2×106 CD34+ cells/kg).
  • Upfront: G-CSF 10µ/kg/day for 4 days, then plerixafor (59% NHL and 72% myeloma achieved target dose of 5×106 CD34+ cells/kg). Upfront plerixafor is not currently reimbursed by the NHS.
  • Preemptive:
    • Chemomobilisation: give plerixafor if peripheral CD34+ cell count <15/µL and once WBC >4×109/L.
    • GCSF mobilisation: give plerixafor if peripheral CD34+ cell count <15/µL after 4 days.
    • Plerixafor can also be given if the day 1 apheresis yield is <1×106/kg.
    • Currently, UK consensus is that there is no minimum CD34+ count at which plerixafor should be avoided (some argue that it should not be given if CD34+ <5/µL for fear of futility).
  • When to stop plerixafor:
    • If a patient’s CD34+ cell count has not risen to >10/µL after an initial dose of plerixafor.
    • No more than 3-4 doses of plerixafor should be given.
  • Plerixafor is capable of inducing successful second PBSC attempts, even if preemptive therapy fails. Hence, if plerixafor does not result in successful PBSC collection during initial mobilisation attempts, then a second mobilisation attempt (either chemomobilisation or GCSF alone) incorporating plerixafor is appropriate.