Trial descriptions
| Trial ID; paper (P) or abstract (A) . | Start year . | Eligibility . | Stem cell source . | No of courses pre-HCT . | Post-HCT maintenance . |
|---|---|---|---|---|---|
| Trials comparing autograft versus chemotherapy | |||||
| Trials with data | |||||
| P EORTC ALL-3/0686111 | 1986 | Age 15-50 y ALL or lymphoblastic NHL | BM | 2 | No |
| P UKALLXII/E299314 | 1993 | Age 15-65 y (initially 60); not t(9;22); in CR after 2 inductions | BM or PB | 3 | No |
| P PETHEMA ALL-9315 | 1993 | Age 30-50 y; one of: WBC > 25, t(9;22), t(4;11), 11q23, t(1;19) | BM or PB | 4 | No |
| P LALA-9416 | 1994 | Age 15-60 y; one of: WBC > 30, t(9;22), t(4;11), t(1;19), 11q23, CNS disease, no CR after 1 induction, myeloid markers | PB | 3-4 | Yes |
| A EORTC ALL-4/0695117 | 1996 | Not t(9;22); age 20-60 y or 15-19 y with one of: WBC > 30, CNS disease, no CR after 1 induction; ALL or lymphoblastic NHL | PB | 3-4 | Yes |
| Trials with no data available | |||||
| P LALA-8510 | 1985 | Age 15-50 y | BM | 2 | No |
| P LALA-8712 | 1987 | Age 15-50 y | BM | 2 | No |
| P Italian 1987 (n = 29)13 | 1989 | Age 12-60 y | BM | 2 | No |
| Trial ID; paper (P) or abstract (A) . | Start year . | Eligibility . | Stem cell source . | No of courses pre-HCT . | Post-HCT maintenance . |
|---|---|---|---|---|---|
| Trials comparing autograft versus chemotherapy | |||||
| Trials with data | |||||
| P EORTC ALL-3/0686111 | 1986 | Age 15-50 y ALL or lymphoblastic NHL | BM | 2 | No |
| P UKALLXII/E299314 | 1993 | Age 15-65 y (initially 60); not t(9;22); in CR after 2 inductions | BM or PB | 3 | No |
| P PETHEMA ALL-9315 | 1993 | Age 30-50 y; one of: WBC > 25, t(9;22), t(4;11), 11q23, t(1;19) | BM or PB | 4 | No |
| P LALA-9416 | 1994 | Age 15-60 y; one of: WBC > 30, t(9;22), t(4;11), t(1;19), 11q23, CNS disease, no CR after 1 induction, myeloid markers | PB | 3-4 | Yes |
| A EORTC ALL-4/0695117 | 1996 | Not t(9;22); age 20-60 y or 15-19 y with one of: WBC > 30, CNS disease, no CR after 1 induction; ALL or lymphoblastic NHL | PB | 3-4 | Yes |
| Trials with no data available | |||||
| P LALA-8510 | 1985 | Age 15-50 y | BM | 2 | No |
| P LALA-8712 | 1987 | Age 15-50 y | BM | 2 | No |
| P Italian 1987 (n = 29)13 | 1989 | Age 12-60 y | BM | 2 | No |
| Trial ID; paper (P) or abstract (A) . | Start year/median follow-up . | Eligibility for HCT . | Conditioning . | GVHD prophylaxis . | No of courses pre-HCT . | Chemo arm . |
|---|---|---|---|---|---|---|
| Trials comparing donor versus no donor receiving chemotherapy | ||||||
| Trials with data | ||||||
| A UKALLXA21 | 1985 | WBC ≥ 50; CNS disease; late remission; t(9;22),t(1;19), or t(4;11) | Center choice | Center choice | 2 | induction + 2 intensification + maintenance to 108w |
| P PMH 9223 | 1992 | Age 16-54 y | TBI + cyclophosphamide | methotrexate + cyclosporin + prednisolone | 3-5 | induction + consolidation + intensification + maintenance to 2y |
| P JALSG-ALL9324 | 1993 | Age < 40 y | NS | NS | 2 | induction + 3 consolidation + 4 intensification + maintenance to 57w |
| P GRAALL 200325 | 2003 | Age ≤ 55 y; B cells and WBC ≥ 30; CNS disease; t(4;11), t(1;19), MLL-AF4, or E2A-PBX1 fusion transcript; low hypodiploidy, near triploidy, or poor response. | TBI + cyclophosphamide | methotrexate + cyclosporin | 4 or 7 | induction + 9 consolidation + intensification + maintenance for 2y. |
| Trials with no data available | ||||||
| P MD Anderson (n = 66)19 | 1980 | High risk | TBI + piperazinedione | methotrexate/T-cell depletion/cyclosporin | 2 | induction + consolidation + intensification + maintenance for 18m |
| Zagreb 83-8820 | 1983 | Age 15-44 y | TBI + cyclophosphamide/busulfan + cyclophosphamide | cyclosporin + methotrexate | 2 | induction + consolidation + (4 consolidation or 1 intense) + maintenance to 4y |
| A City of Hope (n = 105)22 | 1989 | Age < 50 y | TBI + VP16 + cyclophosphamide | methotrexate + prednisolone + cyclosporin | 1-2 | induction + 9 consolidation + intensification + maintenance to 30m |
| Trials comparing donor versus no donor receiving autograft | ||||||
| Trials with data | Pre-allo or auto | Post automaintenance? | ||||
| P HOVON 18 ALL27 | 1992 | Age 15-50 y | TBI + cyclophosphamide | T-cell depletion of graft and cyclosporin | 3 | No |
| P GOELAL0228 | 1994 | Age 15-50 y; one of: age > 35 y, B-ALL, WBC > 30, t(9;22), t(4;11), t(1;19), no CR after 1 induction | TBI + VP16 + cyclophosphamide | NS | 3 | No |
| P NILG ALL08/9629 | 1996 | B-lineage; one of:t(9;22), t(4;11), CD10− blasts ≥ 10 × 109/L | NS melphalan + TBI for auto | NS | ≥ 1 (4 for auto, which was purged) | No |
| P HOVON 37 ALL27 | 1999 | Age 16-55 y | TBI + cyclophosphamide | T-cell depletion of graft and cyclosporin | 3 | Yes (daily 6 MP and weekly methotrexate for a maximum of 1 y vs no maintenance) |
| Trials with no data available | ||||||
| P BGMT 1990 (n = 120)26 | 1990 | Age 15-55 y | TBI + cyclophosphamide | methotrexate + cyclosporin | 3 | IL2 (randomized) |
| Trials comparing donor versus no donor receiving chemotherapy or autograft | ||||||
| Trials with data | Pre-allo | Chemo arm | ||||
| P EORTC ALL-3 /0686111 | 1986 | Age 15-50 y; ALL or lymphoblastic NHL | TBI + cyclophosphamide | methotrexate + cyclosporin/T-cell depletion | 2-3 | induction + consolidation + 6 intensification + maintenance to 3 y |
| P UKALLXII/ECOG E299314 | 1993 | Age 15-55 y (initially 50 y); not t(9;22); in CR after 2 inductions | TBI + VP16 | methotrexate + cyclosporin/T-cell depletion | 3 | 2 induction + Intensification + 4 consolidation + maintenance to 98 wk |
| P PETHEMA ALL-9315 | 1993 | Age 30-50 y; one of: WBC > 25, t(9;22), t(4;11), 11q23, t(1;19) | TBI + cyclophosphamide | methotrexate + cyclosporin | 4 | induction + 6 intensification + maintenance to 2 y |
| P LALA-9416 * | 1994 | Age 15-50 y; one of: WBC > 30, t(9;22), t(4;11), t(1;19), 11q23, CNS disease, no CR after 1 induction, myeloid markers | TBI + cyclophosphamide | methotrexate + cyclosporin/cyclosporin alone | 2 | induction + consolidation + maintenance with intensive blocks for 2 y |
| A EORTC ALL-417 | 1995 | Age 15-50 y; one of: WBC > 30, t(9;22), t(4;11), t(1;19), 11q23, CNS disease, no CR after 1 induction, myeloid markers | TBI + cyclophosphamide | methotrexate + cyclosporin/cyclosporin alone | 2 | induction + consolidation + maintenance with intensive blocks for 2 y |
| Trials with no data available | ||||||
| P LALA-8510 | 1985 | Age 15-40 y (50 y for auto) | TBI + cyclophosphamide | methotrexate + cyclosporin/cyclosporin alone | 1 | induction + 3 consolidation + maintenance for 80 wk |
| P LALA-8718 | 1987 | Age 15-40 y | TBI + cyclophosphamide | methotrexate + cyclosporin/cyclosporin alone | 1 | induction + 3 consolidation + maintenance for 80 wk |
| P Italian 1987 (n = 45)13 | 1987 | Age 12-60 y | NS | NS | 2 | induction + 2 intensification |
| Trial ID; paper (P) or abstract (A) . | Start year/median follow-up . | Eligibility for HCT . | Conditioning . | GVHD prophylaxis . | No of courses pre-HCT . | Chemo arm . |
|---|---|---|---|---|---|---|
| Trials comparing donor versus no donor receiving chemotherapy | ||||||
| Trials with data | ||||||
| A UKALLXA21 | 1985 | WBC ≥ 50; CNS disease; late remission; t(9;22),t(1;19), or t(4;11) | Center choice | Center choice | 2 | induction + 2 intensification + maintenance to 108w |
| P PMH 9223 | 1992 | Age 16-54 y | TBI + cyclophosphamide | methotrexate + cyclosporin + prednisolone | 3-5 | induction + consolidation + intensification + maintenance to 2y |
| P JALSG-ALL9324 | 1993 | Age < 40 y | NS | NS | 2 | induction + 3 consolidation + 4 intensification + maintenance to 57w |
| P GRAALL 200325 | 2003 | Age ≤ 55 y; B cells and WBC ≥ 30; CNS disease; t(4;11), t(1;19), MLL-AF4, or E2A-PBX1 fusion transcript; low hypodiploidy, near triploidy, or poor response. | TBI + cyclophosphamide | methotrexate + cyclosporin | 4 or 7 | induction + 9 consolidation + intensification + maintenance for 2y. |
| Trials with no data available | ||||||
| P MD Anderson (n = 66)19 | 1980 | High risk | TBI + piperazinedione | methotrexate/T-cell depletion/cyclosporin | 2 | induction + consolidation + intensification + maintenance for 18m |
| Zagreb 83-8820 | 1983 | Age 15-44 y | TBI + cyclophosphamide/busulfan + cyclophosphamide | cyclosporin + methotrexate | 2 | induction + consolidation + (4 consolidation or 1 intense) + maintenance to 4y |
| A City of Hope (n = 105)22 | 1989 | Age < 50 y | TBI + VP16 + cyclophosphamide | methotrexate + prednisolone + cyclosporin | 1-2 | induction + 9 consolidation + intensification + maintenance to 30m |
| Trials comparing donor versus no donor receiving autograft | ||||||
| Trials with data | Pre-allo or auto | Post automaintenance? | ||||
| P HOVON 18 ALL27 | 1992 | Age 15-50 y | TBI + cyclophosphamide | T-cell depletion of graft and cyclosporin | 3 | No |
| P GOELAL0228 | 1994 | Age 15-50 y; one of: age > 35 y, B-ALL, WBC > 30, t(9;22), t(4;11), t(1;19), no CR after 1 induction | TBI + VP16 + cyclophosphamide | NS | 3 | No |
| P NILG ALL08/9629 | 1996 | B-lineage; one of:t(9;22), t(4;11), CD10− blasts ≥ 10 × 109/L | NS melphalan + TBI for auto | NS | ≥ 1 (4 for auto, which was purged) | No |
| P HOVON 37 ALL27 | 1999 | Age 16-55 y | TBI + cyclophosphamide | T-cell depletion of graft and cyclosporin | 3 | Yes (daily 6 MP and weekly methotrexate for a maximum of 1 y vs no maintenance) |
| Trials with no data available | ||||||
| P BGMT 1990 (n = 120)26 | 1990 | Age 15-55 y | TBI + cyclophosphamide | methotrexate + cyclosporin | 3 | IL2 (randomized) |
| Trials comparing donor versus no donor receiving chemotherapy or autograft | ||||||
| Trials with data | Pre-allo | Chemo arm | ||||
| P EORTC ALL-3 /0686111 | 1986 | Age 15-50 y; ALL or lymphoblastic NHL | TBI + cyclophosphamide | methotrexate + cyclosporin/T-cell depletion | 2-3 | induction + consolidation + 6 intensification + maintenance to 3 y |
| P UKALLXII/ECOG E299314 | 1993 | Age 15-55 y (initially 50 y); not t(9;22); in CR after 2 inductions | TBI + VP16 | methotrexate + cyclosporin/T-cell depletion | 3 | 2 induction + Intensification + 4 consolidation + maintenance to 98 wk |
| P PETHEMA ALL-9315 | 1993 | Age 30-50 y; one of: WBC > 25, t(9;22), t(4;11), 11q23, t(1;19) | TBI + cyclophosphamide | methotrexate + cyclosporin | 4 | induction + 6 intensification + maintenance to 2 y |
| P LALA-9416 * | 1994 | Age 15-50 y; one of: WBC > 30, t(9;22), t(4;11), t(1;19), 11q23, CNS disease, no CR after 1 induction, myeloid markers | TBI + cyclophosphamide | methotrexate + cyclosporin/cyclosporin alone | 2 | induction + consolidation + maintenance with intensive blocks for 2 y |
| A EORTC ALL-417 | 1995 | Age 15-50 y; one of: WBC > 30, t(9;22), t(4;11), t(1;19), 11q23, CNS disease, no CR after 1 induction, myeloid markers | TBI + cyclophosphamide | methotrexate + cyclosporin/cyclosporin alone | 2 | induction + consolidation + maintenance with intensive blocks for 2 y |
| Trials with no data available | ||||||
| P LALA-8510 | 1985 | Age 15-40 y (50 y for auto) | TBI + cyclophosphamide | methotrexate + cyclosporin/cyclosporin alone | 1 | induction + 3 consolidation + maintenance for 80 wk |
| P LALA-8718 | 1987 | Age 15-40 y | TBI + cyclophosphamide | methotrexate + cyclosporin/cyclosporin alone | 1 | induction + 3 consolidation + maintenance for 80 wk |
| P Italian 1987 (n = 45)13 | 1987 | Age 12-60 y | NS | NS | 2 | induction + 2 intensification |
NS indicates nonspecified; and TBI, total body irradiation.
LALA-94 had 4 risk groups, in 3 of which HCT was recommended. Group 2 received sibling allograft or were randomized between autograft or chemotherapy; groups 3 and 4 received allograft or autograft, with matched unrelated allografts allowed.