In this single centre double-blind randomised trial 39 HLA-identical sibling donrecipient pairs were randomised to receive either BM (n=19,M15,F4;median age:36yr)orPBSC (n=20,M14,F6;median age37yr).The donors underwent BM harv:st followed by PBSC harvest. PBSC were harvested with lenograstim (Granocyte, Chu ;ai Pharma) in the dose of 10 micgm/kg/day for 5 days. BM and PBSC were coded and cryopreserved in identical bags. The stem cell products were quantitated for CD34 c< 11s and the lymphocytes (including the subtypes). The immunological profile was monitored at 1, 3, 6 and 12 mo.The blood samples were analysed for lymphocyte and monocyte End CD4/CD8, CD3, CD25, CD 16, CD 19 counts. The sr. immunoglobulin levels were measur :d. Patients were conditioned with (n = 26) or without TBI(n=13) and all received CyA+Mtx as GVHD prophylaxis. Patients in PBSC group received higher doses/kg of MNC ( 7 vs 3.2, p<0.0001), CD34 (3.7 vs 1.5, p=0.002) and CD3+ cellsf 1.9 vs 0.3, p<0.0001). PBSC arm was associated with faster neutrophil recover (17.5 d vs. 23d, p=0.01), platsjlet recovery (11 vs 18 d; p < 0.0001) less need of parenteral antibiotics (12 vs 16 d; p = O.M7) and earlier hospital discharge (26 vs 30 d; p = 0.01). Lymphocyte count and all [he subtypes increased from Ho 12mo. The median CD4/CD8 ratio was 1.175, 0.75, 0.48 ;nd 0.562 at 1, 3 6, and 12 mo. respectively. At 1 mo. there was no difference in CD3 colint (0.63 vs 0.48,p=0.08), CD8 count (0.127 vs 0.122), CD19 count (0.011 vs 0.003) trat CD25 count (0.08 vs 0.04, p=0.007) and CD4 count was higher in PBSC arm (0.1661 vs 0.087, p = 0.02). 22 patients are alive in CR at a median of 33mo (20-47 mo). 6 patiekits relapsed all receiving BM (2 yr risk 37%, 95% CI 17-68%, p=0.003). 22 patients are alive in remission (BM 9.PBSC13). Mean blood counts beyond 1 yr. (BM 6, PBSC ll) showed no difference in hemoglobin (12.8 vs. 13.6 g/dl), WBC count (6.4 vs 6.1) and platelet count (178 vs 171) but there was a trend towards higher lymphocyte count (2.2 vs 1.7, p=0.062) with PBSC. Patients with higher CD4 levels at Imo. had less TRM and better OS. It appears that use of PBSC is associated with better immune reconstitution but the differences tend to disappear over time. Effect of better CD4 recovery with PBSC needs to be evaluated in larger trials.
|Original language||English (US)|
|Issue number||11 PART I|
|State||Published - Dec 1 2000|
ASJC Scopus subject areas
- Cell Biology