Skip to main content
. Author manuscript; available in PMC: 2018 Jan 1.
Published in final edited form as: Expert Rev Hematol. 2016 Dec 8;10(1):1–8. doi: 10.1080/17474086.2017.1262757

Table 1.

Studies of Nelarabine in Patients with Relapsed and/or Refractory Leukemias.(T-ALL: T Acute Lymphoblastic Leukemia; T-LBL: T Lymphoblastic Lymphoma; D or d: day; EM: extramedullary; CNS: central nervous system)

Reference (Ref. #) Phase N Agent(s) Dose(s) and Schedule N Overall response rate Any Neurotoxicity ≥ Grade 3 Neurotoxicity
Kurtzberg, et. al. (25) I 93 Nelarabine Escalating 5 mg/kg/d - 75 mg/kg/d on D1-5; (MTD 1200 mg/m2/d on D1-5) 93 31% overall 72%
39 54% in T-ALL
Gandhi, et. al. (33) I 13 Nelarabine 1200 mg/m2/d on D1, 3, 5 13 54% 54%
Fludarabine 30 mg/m2/d on D3 and 5
Berg, et. al. (34) II 121 Nelarabine started 1200 mg/m2/d on D1-5, but needed 2 de-escalations to 650 mg/m2/d on D1-5 and 400 mg/m2/d on D1-5 106 Overall - 33% 18%
33 First relapse - 55%
30 Beyond first relapse -27%
21 With CNS disease - 33%
22 With isolated EM disease - 14%
DeAngelo, et. al. (35) II 39 Nelarabine 1500 mg/m2/d on D1, 3, 5 39
(13 T-LBL) 		Overall - 41% 37% peripheral sensory neuropathy 18%
11 First relapse - 55% 21% peripheral motor neuropathy
28 Beyond first relapse - 36%
Gokbuget, et. al. (38) II 126 Nelarabine 1500 mg/m2/d on D1, 3, 5 126
(19 T-LBL) 		46% 16% 7%
Commander, et. al. (46) I 7 Nelarabine 650 mg/m2/d on D1 - 5 7 100% 86% 57%
Etoposide 100 mg/m2/d on D6 - 10
Cyclophosphamide 440 mg/m2/d on D6 - 10
Kadia, et. al. (51) I 23 Nelarabine Escalating doses from 100 - 700 mg/m2/d x 5 days by 24hr continuous infusion 23 Overall - 30% 22% peripheral neuropathy 4%
10 First relapse - 30% 9% muscle weakness
7 Second relapse - 29%
6 Beyond second relpase - 33%
6 Thymic/Mature histology - 50%