|
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]
|
