Demographic and Treatment Characteristics of the Study Population
| . | Ciprofloxacin + Metronidazole . | Ciprofloxacin . | P Value* . |
|---|---|---|---|
| No. of patients | 68 | 66 | |
| Median age (range) (yrs) | |||
| Patients | 36 (17-56) | 37 (15-57) | NS |
| Donors | 37 (14-64) | 38 (22-59) | NS |
| Donor → recipient gender† | |||
| F → F | 21 (31) | 22 (33) | |
| M → M | 21 (31) | 17 (26) | NS |
| M → F | 14 (21) | 15 (23) | |
| F → M | 12 (18) | 12 (18) | |
| Donor type† | |||
| HLA-identical sibling donor | 40 (59) | 40 (61) | |
| Partially HLA-matched family donor | 8 (12) | 11 (17) | NS |
| Matched unrelated donor | 20 (29) | 15 (23) | |
| Ratio sibling donor to alternative donor | 0.41 | 0.40 | |
| Diagnosis† | |||
| Acute lymphoblastic leukemia | 2 (3) | 6 (9) | |
| Acute myelogenous leukemia | 20 (29) | 16 (24) | |
| Chronic myelogenous leukemia | 39 (57) | 39 (59) | NS |
| Malignant lymphoma | 1 (1) | 1 (2) | |
| Multiple myeloma | 4 (6) | 1 (2) | |
| Myelodysplasia | 2 (3) | 3 (5) | |
| Disease stages† | |||
| Early stages‡ | 35 (51) | 41 (62) | NS |
| Advanced stages‡ | 33 (49) | 25 (38) | |
| GVHD prophylaxis† | |||
| Short methotrexate + cyclosporine | 49 (72) | 48 (73) | NS |
| Cyclosporine | 19 (28) | 18 (27) | |
| Myeloablative regimen† | |||
| TBI + cyclophosphamide1-153 | 52 (76) | 55 (83) | NS |
| Chemotherapeutic regimen1-153 | 16 (24) | 11 (17) | |
| Cytomegalovirus-negative donor-recipient combinations† | 24 (35) | 17 (26) | NS |
| . | Ciprofloxacin + Metronidazole . | Ciprofloxacin . | P Value* . |
|---|---|---|---|
| No. of patients | 68 | 66 | |
| Median age (range) (yrs) | |||
| Patients | 36 (17-56) | 37 (15-57) | NS |
| Donors | 37 (14-64) | 38 (22-59) | NS |
| Donor → recipient gender† | |||
| F → F | 21 (31) | 22 (33) | |
| M → M | 21 (31) | 17 (26) | NS |
| M → F | 14 (21) | 15 (23) | |
| F → M | 12 (18) | 12 (18) | |
| Donor type† | |||
| HLA-identical sibling donor | 40 (59) | 40 (61) | |
| Partially HLA-matched family donor | 8 (12) | 11 (17) | NS |
| Matched unrelated donor | 20 (29) | 15 (23) | |
| Ratio sibling donor to alternative donor | 0.41 | 0.40 | |
| Diagnosis† | |||
| Acute lymphoblastic leukemia | 2 (3) | 6 (9) | |
| Acute myelogenous leukemia | 20 (29) | 16 (24) | |
| Chronic myelogenous leukemia | 39 (57) | 39 (59) | NS |
| Malignant lymphoma | 1 (1) | 1 (2) | |
| Multiple myeloma | 4 (6) | 1 (2) | |
| Myelodysplasia | 2 (3) | 3 (5) | |
| Disease stages† | |||
| Early stages‡ | 35 (51) | 41 (62) | NS |
| Advanced stages‡ | 33 (49) | 25 (38) | |
| GVHD prophylaxis† | |||
| Short methotrexate + cyclosporine | 49 (72) | 48 (73) | NS |
| Cyclosporine | 19 (28) | 18 (27) | |
| Myeloablative regimen† | |||
| TBI + cyclophosphamide1-153 | 52 (76) | 55 (83) | NS |
| Chemotherapeutic regimen1-153 | 16 (24) | 11 (17) | |
| Cytomegalovirus-negative donor-recipient combinations† | 24 (35) | 17 (26) | NS |
Abbreviations: HLA, human leukocyte antigen; NS, not significant; TBI, (fractionated) total body irradiation.
Comparison between continuous variables by Wilcoxon rank-sum test; comparisons between frequencies by Fisher’s exact test or Mantel-Haenszel test.
No. of patients (rounded percentage of patients) in each study arm.
Early stages, first complete remission or first chronic phase; advanced stages, after first complete remission or first chronic phase.
TBI: 4 fractions of 2.5 Gy on 4 consecutive days (lung shielded to a total dose of 8 Gy) + cyclophosphamide: 60 mg/kg of body weight IV on 2 consecutive days; chemotherapeutic regimen: 1 mg/kg of body weight busulfan PO every 6 hours on 4 consecutive days followed by 60 mg/kg of body weight cyclophosphamide IV on 2 days.