Table 5.
Nine responders in Randomized Phase (n=32)
| ID # | Age | Diagnosis | Stage of Disease | Cytogenetic Risk Group | No. Prior Regimens | Randomization Arm (Cycle 1) | ±No. Cycles | Best Response | Time to Initial Response (days) | Response Duration (days) |
|---|---|---|---|---|---|---|---|---|---|---|
| 31 | 57 | MDS: RAEB-2 | Refractory | Intermediate | 1* | 0 | 14 | CR-marr | 50 | 349 |
| 34 | 74 | t-MN | Prev. Untreated | Unfavorable | 0 | 1000 | 7 | CR | 59 | 161 |
| 36 | 63 | AML | Relapsed | Intermediate | 1 | 1000 | 5 | CR^ | 98 | 59 |
| 48 | 69 | CMML | Prev. Untreated | Intermediate | 0 | 1000 | 6 | HI-P/HI-E | 28 | 141 |
| 49 | 77 | MDS: RAEB-2 | Refractory | Favorable | 2* | 1000 | 28 | HI-E^ | 161 | 682 |
| 50 | 72 | t-MN | Prev. Untreated | Unfavorable | 0 | 1000 | 28 | CR | 41 | 753 |
| 51 | 53 | AML | Relapsed | Intermediate | 3§ | 0 | 5 | CR^ | 44 | 99 |
| 54 | 64 | MDS | Refractory | Unfavorable | 1 | 1000 | 6 | HI-P | 91 | 56 |
| 55 | 79 | MDS | Relapsed | Unfavorable | 1 | 0 | 5 | HI-P | 28 | 91 |
*
Prior therapy included hypomethylating agent
§
Prior therapy included allogeneic stem cell transplant
±
Number of cycles administered
^
Response was ongoing at the time of discontinuation of study treatment; CR-marr denotes complete response in the marrow HI-N, HI-P, HI-E denote hematologic improvement in neutrophils, platelets or erythroid lineage