Mielcarek 2011.

Methods	Randomised controlled trial with two arms: BMT compared with PBSCT in haematological malignancies Participating centre(s): 3 medical centres in the United States of America (Fred Hutchinson Cancer Research Center in Seattle, Stanford University Medical Center in Stanford, California and City of Hope Medical Center in Duarte, California) Recruitment period: March 1996 to July 1999 175 participants randomised, 172 participants evaluated Intervention arm: 92 participants randomised, 91 participants evaluated (1 participant ineligible) Control arm: 83 participants randomised, 81 participants evaluated (2 participants ineligible) Median follow‐up time: 146 months
Participants	Inclusion criteria: between 12 and 55 years old, any haematologic cancer that can be treated by transplantation, HLA‐identical, related donor, serum creatinine < 1.5 mg/dL, cardiac ejection fraction > 45%, corrected pulmonary carbon monoxide diffusing capacity > 50% as the predicted value, liver function tests less than twice the upper limit of normal Exclusion criteria: not reported Median age: Intervention: 42 years, control: 42 years Recipient/donor sex (male/female): Intervention: 22 pairs, control: 28 pairs Underlying disease: any haematologic cancer that can be treated by transplantation Stage of disease: Intervention arm: 51 participants (56%) less‐advanced or standard‐risk (acute leukaemia in first remission, chronic myeloid leukaemia in chronic phase; lymphoma in first remission, untreated first relapse, or 2nd remission), 40 participants (44%) more advanced or high‐risk (all other stages of these malignancies and all other types of haematological malignancies); control arm: 41 participants (51%) less‐advanced or standard‐risk (acute leukaemia in first remission, chronic myeloid leukaemia in chronic phase; lymphoma in first remission, untreated first relapse, or 2nd remission), 40 participants (49%) more advanced or high‐risk (all other stages of these malignancies and all other types of haematological malignancies) HLA matching: all participants have HLA‐identical related donors
Interventions	Conditioning regimen: Intervention arm: total body irradiation (total dose 12 to 13.5 Gy) + busulphan (N = 13) or + cyclophosphamide (N = 30) or + etoposide (N = 7); chemotherapy alone: busulphan and cyclophosphamide (N = 40), busulphan and thiotepa (N = 1); control arm: total body irradiation (total dose 12 to 13.5 Gy) + busulphan (N = 12) or + cyclophosphamide (N = 24) or + etoposide (N = 13) or + busulphan and cyclophosphamide (N = 3); chemotherapy alone: busulphan and cyclophosphamide (N = 29) GvHD prophylaxis: all participants received methotrexate and cyclosporine Intervention arm: received bone marrow stem cells Control arm: received peripheral blood stem cells
Outcomes	Reported outcomes: incidence of acute GvHD grades II to IV, incidence of acute GvHD grades III to IV, cumulative incidence of extensive chronic GvHD, relapse, overall survival, disease‐free survival Non‐reported outcomes: time to neutrophil and platelet engraftment, neutrophil recovery, incidence of overall chronic GvHD, incidence of non‐relapse mortality, transplant‐related mortality
Notes	Source of funding: "This work was supported by the National Institutes of Health and the Cuyamaca Foundation" Conflict of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Method of randomisation not mentioned, but we assume that central randomisation and allocation was performed using a computer random number generator
Allocation concealment (selection bias)	Low risk	"After random assignment to transplantation with peripheral‐blood cells or bone marrow, the patients were stratified according to treatment centre, age (<30 or >30 years), and stage of cancer (less advanced or more advanced). Within these strata, assignments were balanced in blocks of random size"
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding reported, but we assume that the outcome and the outcome measurement are not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Shortly after randomisation but before the beginning of treatment, three patients were found to be ineligible and were given alternative therapy; the results for these three patients were excluded from further analysis"
Selective reporting (reporting bias)	Low risk	The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified
Other bias	Low risk	The study appears to be free of other sources of bias.