Skip to main content

Table 3 Clinical trials in adults

From: Granulocyte transfusions in children and adults with hematological malignancies: benefits and controversies

# of pts Study type Indications for GTX Remarks/outcome Reference(s)
22 Retrospective Grade IV febrile neutropenia G-CSF only for neutrophil mobilization; when >1010 PMNs were infused, clinical benefit compared with historical controls [89]
11 Case series Invasive Fusarium infection Ninety-one percent response rate [57]
74 Retrospective Treatment of infections In 34 patients (46 %), GTXs were discontinued due to clinical response and neutrophil count recovery [12]
56 Retrospective Severe infection in SAA GTX + G-CSF; Survival at 30, 90 and 180 days was 89, 70 and 66 %, respectively. Survival rate correlated with hematopoietic recovery [58]
24 Retrospective Invasive opportunistic infections GTX + IFN-γ1b + G-CSF or GM-CSF. 60 % ORR 4 weeks after treatment [87]
25 Prospective Progressive uncontrolled infections Donors given G-CSF and dexamethasone, either alone or in combination. Favorable responses in 40 % of patients (especially in those with fungal or Gram-negative infections). One death from severe pulmonary reaction [51]
20 Pilot Neutropenia refractory to G-CSF Favorable response in 8 out of 15 assessable patients (53 %) [53]
19 Phase I/II Infections after HSCT GTXs from community donors (94 %). G-CSF + dexamethasone. Resolution of infection in 8/19 patients (42 %). Overall, four of the 19 patients were alive on day 30 after HSCT. None of the patients with invasive aspergillosis (n = 5) cleared the infection [52]
30 Retrospective Neutropenia and severe infections G-CSF + dexamethasone. In 11 patients, resolution of infection could be related to granulocyte transfusions. Three of these patients became long-term survivors [54]
52 Prospective Control or prevention of severe infections Control of infections was achieved in 82 % of life-threatening episodes. No reactivation of infections occurred under prophylactic granulocyte transfusions [55]
100 Randomized (GRANITE study) Febrile neutropenia Ongoing national, multi-center trial; Patients aged 1–75 years (www. drks.de/DRKS00000218); Date of first enrollment: October 2014; Arm 1 (intervention-group): transfusion of standardized leukapheresis products of granulocytes on every other day + standard therapy; arm 2 (control group): standard-therapy without granulocyte transfusions NA
30 Prospective (GIN1 study) Febrile neutropenia Granulocytes derived from whole blood; risk of adverse events comparable to other granulocyte components; recovery of neutrophils and survival in all patients except for two adult patients who died [26]
114 Randomized (RING study) Febrile neutropenia Composite endpoint was survival + microbial response 42 days after randomization; 42 and 43 % success rates for the granulocyte and control groups, respectively NCT00627393; [56]
  1. Completed and ongoing clinical trials of therapeutic granulocyte transfusions in adults are summarized
  2. HSCT hematopoietic stem cell transplantation, DXM dexamethasone, OS overall survival, ORR overall response rate