Heldal 2003.

Methods	Randomised controlled trial with two arms: BMT compared with PBSCT in haematological malignancies Participating centre(s): 1 BMT centre in Oslo, Norway Recruitment period: June 1994 to February 1999 61 participants randomised, 60 participants evaluated Intervention arm: 30 participants randomised, 30 participants evaluated Control arm: 31 participants randomised, 30 participants evaluated (1 participants excluded after randomisation with no reason mentioned) Median follow‐up time: 60 months
Participants	Inclusion criteria: adult, haematological malignancies, HLA‐identical or one antigen‐mismatched haploidentical family donor Median age: Intervention: 45 years, control: 39 years Recipient/donor sex (male/female): Intervention: 4 pairs, control: 9 pairs Underlying disease: chronic myeloid leukaemia in chronic phase, acute myeloid leukaemia in complete remission and early relapse, acute lymphoid leukaemia in complete remission and early relapse, myelodysplastic syndrome, primary myelofibrosis Stage of disease: not specified HLA matching: HLA‐identical or one antigen‐mismatched haploidentical family donor
Interventions	Conditioning regimen: all participants received busulphan (16 mg/kg) and cyclophosphamide (120 mg/kg) and intrathecal methotrexate 12 mg/kg for recipients with acute myeloid leukaemia M4/5 or acute lymphoblastic leukaemia on days ‐8 and ‐4 and four times after transplantation GvHD prophylaxis: all participants received cyclosporine from day ‐1 until +180 and methotrexate intravenously 15 mg/m² on days +3, +6, +11 (if there are no signs of serious liver toxicity) Intervention arm: received bone marrow stem cells Control arm: received peripheral blood stem cells
Outcomes	Reported outcomes: disease‐free survival, transplant‐ related mortality Non‐reported outcomes: time to neutrophil and platelet engraftment, incidence of acute GvHD, incidence of overall chronic GvHD and extensive GvHD, incidence of relapse and non‐relapse mortality, overall survival
Notes	Source of funding: "This study was supported by Bergliot and Sigurd Skaugen's 'Fond Til Bekjempelse av Kreft' 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	"The 61 patients were stratified according to age, but not to HLA mismatch, stage of disease or other prognostic factors. Subsequently, they were randomised on blocks of six, three for each type of cell harvest."
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	High risk	One patient excluded after randomisation with no reason mentioned.
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 pre‐specified.
Other bias	Low risk	The study appears to be free of other sources of bias.