Table 4.

Best protocol response

Dose levelDose, µg/kgNumber treatedNumber evaluablecCRPRHematologic activityStable diseaseProgressive diseaseNot evaluable
1A5111
2A10111 (CRi)
3A20111
3B2044121
4A304431
4B30541 (MRD negative)1111
5B40871 (MRD negative)3211
5C32* (40)117211124
6B50662 (1 MRD negative)13
6C5014122 CR (1 MRD negative), 1 CRi (MRD negative)21512
554711 (23%)4 (9%)11 (23%)12 (26%)9 (19%)8
  • Response rates based on evaluable population (response criteria listed in Table 1). Cohorts: A: every other day × 6 doses, no steroids; B: every other day × 6 doses, dexamethasone prophylaxis cycle 1; C: every other day × 10 doses, dexamethasone prophylaxis cycle 1, doses 1 to 6.

  • CRi, CR with incomplete blood count recovery.

  • * 32 µg/kg process 3 equivalent bioactivity to 40 µg/kg of prior product.