ALL-SZT BFM 2003

Main objectives

• To evaluate whether haematopoietic stem cell transplantation (HSCT) from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).
• To compare the efficacy of HSCT between mismatched family or unrelated donors (MMD) and matched donors (MSD/MD).
• To determine whether therapy has been carried out according to the main HSCT ALL-SCT BFM protocoll recommendations.
• The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison between survival after HSCT and survival after chemotherapy only.
• To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.

Secondary objectives

• To prospectively evaluate survival and event free survival after HSCT from matched sibling donors (MSD), from matched family or unrelated donors (MD) and from mismatched family or unrelated donors (MMD).
• To reduce transplantation associated mortality by standardising the selection criteria for donors, the stem cell manipulation and supportive measures for allogeneic HSCT.
• To prevent extensive chronic GvHD by close monitoring and by using standardised GvHD and anti-infectious therapy.

The stratification into the single transplantation modalities for patients in first or second remission is specified by the indication and the availibility of a donor in the single groups for transplantation. The criteria for the indication are defined by the AIEOP/ALL -BFM trial, the Interfant trial, the COALL trial and the ALL-REZ trial. The choice of the therapy regimen is determined by the chosen donor independend of the given indication. Within the donor group the conditioning will be stratified depending of the age of the patient, genetic factors [presence of t(4;11)] and the feasibility of a whole body irradiation.

• Age at ALL diagnosis (for HSCT indication in first complete remission) or at ALL relapse diagnosis: ≤18 years
• ALL in first, second or any following complete remission
• Indication for allogeneic HSCT signed informed consent of parents or legal guardian of the minor patient (and in certain cases of the patient himself/herself) for participation in the study ALL SCT BFM 2003.
• The patient is treated in a hospital participating in the study during the study period.
• No pregnancy
• No secondary malignancy
• No history of allogeneic or autologous HSCT
• The patient is study patient in a ALL-BFM or ALL-REZ or COALL trial