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Predictors of recovery from poor graft function
Table 1. Allogeneic stem cell transplant characteristics.
continued from the previous coloum
Characteristics
Number
Recipient age, median (range), years
Recipient sex Male
Female
Disease
Lymphoproliferative disorder Acute myeloid leukemia Acute lymphoblastic leukemia Myelodysplastic syndrome Severe aplastic anemia Primary myelofibrosis Primary immunodeficiency Chronic myeloid leukemia Sickle cell disease
EBMT Risk Score*
Early disease stage
Intermediate disease stage
Late stage disease
Not applicable (non-malignant disease)
HCT-CI Low risk
Intermediate risk
High risk
Donor type
Related donor
Matched unrelated donor Mismatched unrelated donor
CMV status (R/D) Negative/negative Other
ABO status (R/D) Major incompatibility Minor incompatibility No incompatibility
Sex matching Matched
Unmatched
Acute GvHD Grades 0-I Grades II-IV
Chronic GvHD None
Mild
Moderate Severe
Non evaluable**
CMV reactivation Yes
No
Conditioning regimen RIC (FMC) Other***
Source of stem cells Bone marrow Peripheral blood
Median CD34 dose (x106/kg) (range)
T-cell depletion Yes
No
N. of patients (%)
62
49 (10-66)
35 (57%) 27 (43%)
30 (48%) 11 (18%) 7 (11%) 5 (8%) 3 (5%) 2 (3%) 2 (3%) 1 (2%) 1 (2%)
19 (31%) 28 (45%) 9 (14%) 6 (10%)
45 (73%) 15 (24%) 2 (3%)
28 (45%) 18 (29%) 16 (25%)
23 (37%)
39 (63%)
14 (23%) 13 (21%) 35 (57%)
31 (50%)
31 (50%)
42 (68%) 20 (32%)
37 (60%) 11 (18%) 9 (15%) 3 (5%) 2 (3%)
35 (56%) 27 (44%)
40 (65%)
22 (35%)
8 (13%) 54 (87%)
5.0 (0.3-37.6) 57 (92%)
5 (8%)
Poor graft function Primary
Secondary
Chimerism pre-CD34+- infusion Donor
Mixed
Missing values
21 (34%)
41 (66%)
21 (34%) 32 (52%) 9
EBMT: European Group for Blood and Marrow Transplantation; HCT-CI: Hematopoietic Cell Transplantation-specific Comorbidity Index; CMV: cytomegalovirus; R/D: recipient/donor; GvHD: graft-versus-host disease; RIC: reduced intensity conditioning; FMC: fludarabine, melphalan, alematuzumab. *EBMT Risk Score: early disease stage includes acute leukemia (AL) transplanted in first com- plete remission (CR), myelodysplastic syndrome (MDS) transplanted untreated or in first CR; intermediate disease stage includes AL in second CR, chronic myeloid leukemia (CML) in all other stages than first chronic phase or blast crisis,MDS in sec- ond CR or in partial remission (PR),lymphoma and multiple myeloma in second CR, in PR or stable disease; late disease stage includes AL in all other disease stages, CML in blast crisis, MDS in all other disease stages and lymphoma and multiple myeloma in all disease stages other than those defined as early or intermediate. Stage is not applicable for aplastic anemia, primary immunodeficiencies and sickle cell disease. **Patients died within 100 days after allogeneic stem cell transplantation. ***Conditioning regimen (other): Campath 1H/thiotepa/total body irradiation (TBI) (n=1); Campath 1H/cyclophosphamide/TBI (n=2); Campath 1H/fluradabine/ cyclophosphamide/TBI (n=1); cyclophosphamide/TBI (n=3); fluradabine/ cyclophosphamide/TBI (n=3); Campath 1H/BEAM (carmustine, etoposide, cytara- bine, melphalan) (n=5); fluradabine/thiotepa (n=1); Campath 1H/ fluradabine/busul- fan (n=2); Campath 1H/fluradabine/treosulfan (n=1); Campath 1H/ cyclophos- phamide (n=1); antithymocyte globulin/fluradabine/busulfan (n=1); cyclophos- phamide/ fluradabine/TBI (n=1).
Results
Primary and secondary poor graft function
The overall incidence of poor graft function treated with CD34+-selected infusion was 3.1% (62/1996) among the total population of patients transplanted. Twenty-one patients in this group (34%) had primary poor graft func- tion and 41 had secondary poor graft function (66%). The median time from engraftment to the development of sec- ondary poor graft function was 130 days (range, 5-2,694). Poor graft function was restricted to one or two hematopoietic cell lineages in 19 patients (31%), and occurred in all three lineages in 43 patients (69%), although patients with primary poor graft function were more likely to have trilineage cytopenia than those with secondary poor graft function (19 of 21 [91%] versus 24 of 41 [61%], respectively; P=0.01). In a multivariate analysis to determine factors associated with primary versus sec- ondary poor graft function, a mismatched unrelated donor was associated with a higher probability of primary poor graft function (P=0.03), whereas CMV serostatus other than negative for both recipient and donor was associated with a higher risk of secondary poor graft function (P=0.008). No other significant associations for primary versus secondary poor graft function in the treated group were found for any of the following factors: donor-recipi- ent sex matching, donor-recipient age, Hematopoietic Cell Transplantation-specific Comorbidity Index, European Group for Blood and Marrow Transplantation (EBMT) Risk Score, presence of GvHD, major ABO incompatibili- ty or the original transplant CD34+ cell dose (Online Supplementary Tables S2 and S3).
Hematologic improvement following CD34+-selected infusion
The median interval from allogeneic SCT to CD34+- selected infusion was 15 months (range, 1-226); the medi-
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