Table 1. Clinical trials sponsored by CCG during 1988-2002.
| Trial | Accrual dates | Risk group | Study Question | N | 5- year EFS±SE1 | # of Relapses (% per protocol) | Median (range) length of CR12 | Median follow-up time3 | Median follow-up time4 |
|---|---|---|---|---|---|---|---|---|---|
| 1881 | 12/88-12/92 | Low | Randomization of DI5 vs. standard therapy. | 778 | 79.9±1.5% | 152 (19.5%) | 36.1 (2.6, 120.9) | 91.9 | 49.0 |
| 1882 | 5/89-6/95 | Higher | Efficacy of post-induction intensification for higher risk patients with a slow response to initial therapy. | 1525 | 68.3±1.3% | 388 (25.4%) | 23.1 (0.1, 113.4) | 35.7 | 8.6 |
| 1883 | 12/88-8/93 | Infant | Treatment of infants less than 12 months of age. | 135 | 37.6±4.3% | 75 (55.6%) | 5.5 (0.6, 69.3) | 16.6 | 6.6 |
| 1891 | 1/90-7/93 | Intermediate | Efficacy of double DI vs. single DI | 1204 | 79.6±1.2% | 223 (18.5%) | 28.7 (0.6, 124.8) | 73.7 | 33.7 |
| 1901 | 12/90-9/94 | High | Treatment of newly diagnosed children with multiple unfavorable presenting features | 418 | 73.0±2.3% | 79 (18.9%) | 16.1 (1.7, 67.8) | 28.9 | 8.7 |
| 1922 | 3/93-8/95 | Standard | Randomized comparison IV vs. oral 6-MP and dexamethasone vs. prednisone | 1061 | 82.3±1.3% | 179 (16.9%) | 30.5 (2.1, 86.7) | 67.7 | 25.0 |
| 1952 | 5/96-2/00 | NCI Standard | Randomized comparison of oral 6-MP vs. 6-TG and intrathecal MTX vs ITT. | 2174 | 81.7±0.1% | 371 (17.1%) | 31.5 (0.5, 110.6) | 69.0 | 26.6 |
| 1953 | 7/96-8/00 | Infant | Treatment of infants with intensive early systemic and intrathecal therapy. | 115 | 43.1±4.9% | 24 (20.9%) | 8.9 (1.1, 69.2) | 14.1 | 4.0 |
| 1961 | 9/96-5/02 | NCI High | Randomized comparison of standard versus augmented BFM and single versus double DI. | 2057 | 71.5±1.3% | 443 (21.5%) | 21.1 (0.2, 112.2) | 37.2 | 9.9 |
| 1962 | 3/97-11/98 | NCI Standard | Randomized comparison of PEG-asparaginase with native E.coli asparaginase on the standard arm of the CCG-1952 trials. | 118 | 78.8±4.3% | 27 (22.9%) | 30.2 (6.7, 93.1) | 68.6 | 24.1 |
| Total | 9585 | 1961 | 26.0 (0.1, 124.8) | 51.6 | 15.7 |
1
Standard error
2
Only among relapsed ALL patients (time in months)
3
Median follow-up time (time in months) for relapsed patients from initial diagnosis
4
Median follow-up time (time in months) for relapsed patients from relapse diagnosis
5
DI=Delayed Intensification