OBJECTIVES: To develop a leukemia-specific subscale for the Functional Assessment of Cancer Therapy (FACT) and assess the linguistic validity of Afrikaans, Arabic, Czech, Korean, Portuguese, Slovak and Spanish translations. METHODS: The leukemia-specific subscale was developed through item generation from literature review and interviews with clinical experts and patients in 9 countries. The FACT-Leukemia (FACT-Leu) was then translated using the standard FACIT methodology: 2 forward translations, reconciling of the 2 forwards, back-translation to English, and 3 independent bilingual reviews. The sample included 115 patients (57% male, mean age 46 years) from 8 countries: South Africa, Egypt, Czech Republic, Brazil, Korea, Slovak Republic, Spain, and US (Spanish). Patients diagnosed with leukemia completed the FACT-Leu in their native language and then offered structured input on problems with translation or content. Statistical and reliability analyses were performed, and the participant comments were analyzed qualitatively. RESULTS: The Leu subscale had good reliability with the combined sample (alpha=0.88) and the Spanish sample (alpha=0.88). There were no negative patient comments related to the FACT-Leu items in any language. In addition, all leukemia subscale items had good item-total correlations in the combined sample. Item-total correlations in the individual language samples were reviewed to identify potential translation errors. Four items were flagged with this procedure: appetite, bleeding, bruising, and worry about infections. These translations were reviewed to ensure that the translation was not the cause of the relatively low item-total correlation. One minor revision was made to the Spanish and Afrikaans versions after testing. CONCLUSIONS: The FACT-Leu showed good reliability and linguistic validity in the seven-language combined sample and in the Spanish sample, and good linguistic validity across the individual languages. These results contributed to a better understanding of how quality of life issues are perceived by leukemia patients in different countries and supported cross-cultural comparability of instrument scores.