Clinical features of intent-to-treat patients
| Characteristic . | Study number* . | Total . | ||||
|---|---|---|---|---|---|---|
| (001) . | (002) . | (003) . | (005) . | (004) . | ||
| No. of patients | 3 | 28 | 13 | 15 | 10 | 69 |
| Newly diagnosed | 0 | 0 | 13 | 15 | 4 | 32 |
| Prior treatment | 3 | 28 | 0 | 0 | 6† | 37 |
| Enrollment (mo/y) | 3/93-10/95 | 5/95-5/99 | 8/97-5/99 | 8/97-5/99 | 8/97-5/99 | |
| Age (y) | ||||||
| Median | 24 | 44 | 34 | 54 | 28 | 44 |
| Range | 24-48 | 19-70 | 5-82 | 10-77 | 11-64 | 5-82 |
| Males (no.) | 1 | 18 | 6 | 10 | 5 | 40 (58%) |
| Race (no.) | ||||||
| White | 1 | 13 | 5 | 11 | 3 | 33 (48%) |
| Latino | 2 | 10 | 3 | 4 | 6 | 25 (36%) |
| Black | 0 | 3 | 0 | 0 | 0 | 3 (4%) |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 (0%) |
| Other | 0 | 2 | 5‡ | 0 | 1 | 8 (12%) |
| WBC (cells/μL)1-153 | ||||||
| Median | 1.1 | 2.2 | 2.0 | 5.1 | 15.1 | 2.5 |
| Range | 0.8-1.2 | 0.6-16.4 | 0.5-73.3 | 0.4-42 | 0.9-77 | 0.4-77 |
| > 10 000 (no. pts.) | 0 | 2 | 2 | 7 | 6 | 17 |
| Characteristic . | Study number* . | Total . | ||||
|---|---|---|---|---|---|---|
| (001) . | (002) . | (003) . | (005) . | (004) . | ||
| No. of patients | 3 | 28 | 13 | 15 | 10 | 69 |
| Newly diagnosed | 0 | 0 | 13 | 15 | 4 | 32 |
| Prior treatment | 3 | 28 | 0 | 0 | 6† | 37 |
| Enrollment (mo/y) | 3/93-10/95 | 5/95-5/99 | 8/97-5/99 | 8/97-5/99 | 8/97-5/99 | |
| Age (y) | ||||||
| Median | 24 | 44 | 34 | 54 | 28 | 44 |
| Range | 24-48 | 19-70 | 5-82 | 10-77 | 11-64 | 5-82 |
| Males (no.) | 1 | 18 | 6 | 10 | 5 | 40 (58%) |
| Race (no.) | ||||||
| White | 1 | 13 | 5 | 11 | 3 | 33 (48%) |
| Latino | 2 | 10 | 3 | 4 | 6 | 25 (36%) |
| Black | 0 | 3 | 0 | 0 | 0 | 3 (4%) |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 (0%) |
| Other | 0 | 2 | 5‡ | 0 | 1 | 8 (12%) |
| WBC (cells/μL)1-153 | ||||||
| Median | 1.1 | 2.2 | 2.0 | 5.1 | 15.1 | 2.5 |
| Range | 0.8-1.2 | 0.6-16.4 | 0.5-73.3 | 0.4-42 | 0.9-77 | 0.4-77 |
| > 10 000 (no. pts.) | 0 | 2 | 2 | 7 | 6 | 17 |
WBC = white blood cell count; pts = patients.
Phase I (001): relapse; Phase II: 002 (relapse); 003 and 005 (previously untreated, newly diagnosed); 004 (compassionate plea).
Two of these patients failed oral all-trans retinoic acid (ATRA) and, were switched to the liposomal form.
Includes one patient with ethnicity unknown.
WBC at presentation before any treatment and before hydroxyurea or leukaphersis.