Complications
| . | Tt-BuCy . | ATG-BuCy . | P . |
|---|---|---|---|
| No. of patients | 30 | 51 | |
| Transplant-related deaths | 4 (13%) (2 BO, 1 encephalitis, 1 TMA) | 3 (6%) (2 aGVHD, 1 sepsis) | .414 |
| Severe mucositis* | 7 (23%) | 1 (2%) | .003 |
| Severe hemorrhagic cystitis* | 3 (10%) | 7 (14%) | .737 |
| Hypertension stage 2 | 13 (43%) | 26 (51%) | .646 |
| aGVHD > grade 2 | 1 (3%) (grade 3) | 4 (8%) (3 grade 3, 1 grade 4) | .648 |
| cGVHD > mild | 3 (10%) (all BO) | 2 (4%) (1 BO, 1 NS) | .350 |
| Immune cytopenias | 0 | 1 (2%) (ITP) | 1.000 |
| Sinusoidal obstructive syndrome | 2 (7%) | 1 (2%) | .551 |
| Thrombotic microangiopathy | 3 (10%) | 1 (2%) | .136 |
| CMV-positive recipient | 100% | 100% | 1.000 |
| CMV-negative donor | 5 (17%) | 7 (14%) | .753 |
| CMV reactivation | 13 (43%) | 7 (14%) | .006 |
| Central venous line infection | 5 (17%) | 17 (33%) | .126 |
| Clinical sepsis | 2 (7%) | 7 (13%) | .473 |
| Fungal infection (proven or probable) | 0 | 0 | 1.000 |
| Empirical use of antifungals | 3 (10%) | 5 (10%) | 1.000 |
| Tuberculosis | 1 (3%) | 1 (2%) | 1.000 |
| Malaria | 1 (3%) | 0 | .370 |
| Other | 2 intracranial hemorrhage, 1 encephalitis | 1 cutaneous leishmaniasis, 1 endocarditis, 1 Salmonella bacteremia, 1 HAV infection | |
| Immunosuppression withdrawal | 409 (158-562) | 320 (101-419) | .013 |
| Mixed chimerism (5%-99%) with transfusion independence | 20 of 25 evaluable cases (80%) | 39 of 44 evaluable cases (87%) | .478 |
| Level 1 (90%-99% donor) | 20 | 32 | .506 |
| Level 2 (75%-89% donor) | 0 | 3 | .549 |
| Level 3 (5%-74% donor) | 0 | 4 | .289 |
| . | Tt-BuCy . | ATG-BuCy . | P . |
|---|---|---|---|
| No. of patients | 30 | 51 | |
| Transplant-related deaths | 4 (13%) (2 BO, 1 encephalitis, 1 TMA) | 3 (6%) (2 aGVHD, 1 sepsis) | .414 |
| Severe mucositis* | 7 (23%) | 1 (2%) | .003 |
| Severe hemorrhagic cystitis* | 3 (10%) | 7 (14%) | .737 |
| Hypertension stage 2 | 13 (43%) | 26 (51%) | .646 |
| aGVHD > grade 2 | 1 (3%) (grade 3) | 4 (8%) (3 grade 3, 1 grade 4) | .648 |
| cGVHD > mild | 3 (10%) (all BO) | 2 (4%) (1 BO, 1 NS) | .350 |
| Immune cytopenias | 0 | 1 (2%) (ITP) | 1.000 |
| Sinusoidal obstructive syndrome | 2 (7%) | 1 (2%) | .551 |
| Thrombotic microangiopathy | 3 (10%) | 1 (2%) | .136 |
| CMV-positive recipient | 100% | 100% | 1.000 |
| CMV-negative donor | 5 (17%) | 7 (14%) | .753 |
| CMV reactivation | 13 (43%) | 7 (14%) | .006 |
| Central venous line infection | 5 (17%) | 17 (33%) | .126 |
| Clinical sepsis | 2 (7%) | 7 (13%) | .473 |
| Fungal infection (proven or probable) | 0 | 0 | 1.000 |
| Empirical use of antifungals | 3 (10%) | 5 (10%) | 1.000 |
| Tuberculosis | 1 (3%) | 1 (2%) | 1.000 |
| Malaria | 1 (3%) | 0 | .370 |
| Other | 2 intracranial hemorrhage, 1 encephalitis | 1 cutaneous leishmaniasis, 1 endocarditis, 1 Salmonella bacteremia, 1 HAV infection | |
| Immunosuppression withdrawal | 409 (158-562) | 320 (101-419) | .013 |
| Mixed chimerism (5%-99%) with transfusion independence | 20 of 25 evaluable cases (80%) | 39 of 44 evaluable cases (87%) | .478 |
| Level 1 (90%-99% donor) | 20 | 32 | .506 |
| Level 2 (75%-89% donor) | 0 | 3 | .549 |
| Level 3 (5%-74% donor) | 0 | 4 | .289 |
Bold type indicates statistical significance.
HAV, hepatitis A virus; ICH, intracranial hemorrhage; ITP, immune thrombocytopenic purpura; NS, nephritic syndrome.
Greater than ECOG grade 2.