Ongoing Phase II to IV studies in Philadelphia chromosome–negative acute lymphoblastic leukemia (ALL).
| Study group . | Study name . | Age range, y . | Study type . | Main study question/aim . |
|---|---|---|---|---|
| * funded in UK, in set-up. | ||||
| Abbreviations: MRD, minimal residual disease; HSCT, hematopoietic stem cell transplantation; CR, complete response; MTX, methotrexate; CNS, central nervous system; MARALL, Monoclonal Antibodies in Relapsed ALL; MDACC, M.D. Anderson Cancer Center | ||||
| GIMEMA (Italy) | GIMEMA0904 | 15–60 | Phase IV | Intensification of post-remission therapy in high-risk ALL according to MRD monitoring. |
| GMALL (Germany) | GMALL02 | > 55 | Phase IV | Reduced-dose chemotherapy plus rituximab. |
| GMALL (Germany) | GMALL01 | 15–65 | Phase IV | Efficacy and tolerability of intensified induction and consolidation with subsequent therapy stratified to relapse risk. MRD- based evaluation of therapy continuation. |
| GMALL (Germany) | GMALL03 | 15–65 | Phase IV | Efficacy and tolerability of intensified induction and consolidation in combination with rituximab with subsequent therapy stratified to relapse risk. MRD-based evaluation of therapy continuation. |
| NILG (Italy) | 09/00 | 15–65 | Phase IV | Variable intensity of post-remission therapy according to MRD. |
| PETHEMA (Spain) | LAL-RI/96 | ≥15 | Phase IV | Improving outcome by chemotherapy intensification in adults not for HSCT in CR1. |
| PETHEMA (Spain) | LAL-AR-03 | 30–60 | Phase IV | Protocol for high-risk ALL to evaluate chemotherapy or allogeneic HSCT according to early cytological response and MRD post-consolidation. |
| GRAALL (France) | GRAALL 2005 | 18–59 | Randomized Phase III | Risk stratified. Randomizations between standard vs. intensified cyclophosphamide during late intensification/rituximab vs. no rituximab during induction and consolidation. |
| JALSG (Japan) | ALL202-O | 25–64 | Randomized Phase III | High-dose (3 g/m2) vs. intermediate dose (1.5 g/m2) MTX during most remission therapy |
| NCRI (UK) Children’s Cancer and Leukaemia Group | UKALL2003 | 1–24 | Randomized Phase III | Age-stratified. For 16–24 years, MRD-based randomizations to more intensive therapy. |
| NCRI (? with ECOG and SWOG) | UKALL14/E2907*20–65 | Randomized Phase III | Rituximab, epratuzumab, or both vs. standard chemotherapy | |
| PALG (Poland) | PALG 5-2007 | 16–60 | Phase III | To demonstrate that individualized therapy according to risk factors and monitoring of MRD results in improved outcome. |
| SWOG | SWOG | > 60 | Randomized Phase III | Liposomal vincristine compared to conventional vincristine. |
| GMALL (Germany) | GMALL06 | ≥18 | Phase II | Liposomal cytarabine in patients with CNS relapse. |
| GMALL (Germany) | GMALL07 | ≥18 | Phase II | Tolerability of CAMPATH in relapsed T-cell ALL. |
| JALSG (Japan) | ALL202-U | 15–24 | Phase II | Feasibility of a pediatric-based treatment in young patients. |
| NCRI (UK) | MARALL | 20–65 | Phase II | Humanized antiCD20 plus antiCD22 plus chemotherapy in relapsed ALL. |
| Dana-Farber/Harvard (US) | 06-254 | 18–50 | Phase II | Safety and efficacy of a pediatric regimen including pegylated L-asp. |
| CALGB (US) with COG (US) | CALGB 10403/ AALL0232 | 16–29 | Phase II | Efficacy and tolerability of a pediatric regimen in patients up to the age of 30. |
| MDACC | 2006-0328 | No restrictions | Phase II | Hyper-CVAD with nelarabine in untreated T ALL. |
| MDACC | ID02-230 | No restrictions | Phase II | Modified Hyper-CVAD with or without rituximab. |
| MDACC | ID02-229 | No restrictions | Phase II | Hyper-CVAD and rituximab (for Burkitt-type). |
| SWOG | SWOGS0333 | 18–64 Phase II | Toxicity of an induction and consolidation schedule. Prognostic value of MRD. Gene expression studies. | |
| NCRI (UK) | MRD feasibility study | 20–65 N/A | Non-interventional. To determine ability to deliver molecular MRD nationally, in real time. | |
| Study group . | Study name . | Age range, y . | Study type . | Main study question/aim . |
|---|---|---|---|---|
| * funded in UK, in set-up. | ||||
| Abbreviations: MRD, minimal residual disease; HSCT, hematopoietic stem cell transplantation; CR, complete response; MTX, methotrexate; CNS, central nervous system; MARALL, Monoclonal Antibodies in Relapsed ALL; MDACC, M.D. Anderson Cancer Center | ||||
| GIMEMA (Italy) | GIMEMA0904 | 15–60 | Phase IV | Intensification of post-remission therapy in high-risk ALL according to MRD monitoring. |
| GMALL (Germany) | GMALL02 | > 55 | Phase IV | Reduced-dose chemotherapy plus rituximab. |
| GMALL (Germany) | GMALL01 | 15–65 | Phase IV | Efficacy and tolerability of intensified induction and consolidation with subsequent therapy stratified to relapse risk. MRD- based evaluation of therapy continuation. |
| GMALL (Germany) | GMALL03 | 15–65 | Phase IV | Efficacy and tolerability of intensified induction and consolidation in combination with rituximab with subsequent therapy stratified to relapse risk. MRD-based evaluation of therapy continuation. |
| NILG (Italy) | 09/00 | 15–65 | Phase IV | Variable intensity of post-remission therapy according to MRD. |
| PETHEMA (Spain) | LAL-RI/96 | ≥15 | Phase IV | Improving outcome by chemotherapy intensification in adults not for HSCT in CR1. |
| PETHEMA (Spain) | LAL-AR-03 | 30–60 | Phase IV | Protocol for high-risk ALL to evaluate chemotherapy or allogeneic HSCT according to early cytological response and MRD post-consolidation. |
| GRAALL (France) | GRAALL 2005 | 18–59 | Randomized Phase III | Risk stratified. Randomizations between standard vs. intensified cyclophosphamide during late intensification/rituximab vs. no rituximab during induction and consolidation. |
| JALSG (Japan) | ALL202-O | 25–64 | Randomized Phase III | High-dose (3 g/m2) vs. intermediate dose (1.5 g/m2) MTX during most remission therapy |
| NCRI (UK) Children’s Cancer and Leukaemia Group | UKALL2003 | 1–24 | Randomized Phase III | Age-stratified. For 16–24 years, MRD-based randomizations to more intensive therapy. |
| NCRI (? with ECOG and SWOG) | UKALL14/E2907*20–65 | Randomized Phase III | Rituximab, epratuzumab, or both vs. standard chemotherapy | |
| PALG (Poland) | PALG 5-2007 | 16–60 | Phase III | To demonstrate that individualized therapy according to risk factors and monitoring of MRD results in improved outcome. |
| SWOG | SWOG | > 60 | Randomized Phase III | Liposomal vincristine compared to conventional vincristine. |
| GMALL (Germany) | GMALL06 | ≥18 | Phase II | Liposomal cytarabine in patients with CNS relapse. |
| GMALL (Germany) | GMALL07 | ≥18 | Phase II | Tolerability of CAMPATH in relapsed T-cell ALL. |
| JALSG (Japan) | ALL202-U | 15–24 | Phase II | Feasibility of a pediatric-based treatment in young patients. |
| NCRI (UK) | MARALL | 20–65 | Phase II | Humanized antiCD20 plus antiCD22 plus chemotherapy in relapsed ALL. |
| Dana-Farber/Harvard (US) | 06-254 | 18–50 | Phase II | Safety and efficacy of a pediatric regimen including pegylated L-asp. |
| CALGB (US) with COG (US) | CALGB 10403/ AALL0232 | 16–29 | Phase II | Efficacy and tolerability of a pediatric regimen in patients up to the age of 30. |
| MDACC | 2006-0328 | No restrictions | Phase II | Hyper-CVAD with nelarabine in untreated T ALL. |
| MDACC | ID02-230 | No restrictions | Phase II | Modified Hyper-CVAD with or without rituximab. |
| MDACC | ID02-229 | No restrictions | Phase II | Hyper-CVAD and rituximab (for Burkitt-type). |
| SWOG | SWOGS0333 | 18–64 Phase II | Toxicity of an induction and consolidation schedule. Prognostic value of MRD. Gene expression studies. | |
| NCRI (UK) | MRD feasibility study | 20–65 N/A | Non-interventional. To determine ability to deliver molecular MRD nationally, in real time. | |