TABLE I.

Characteristics of eligible patients (n = 22)

Patient ID	Valspodar dose level	Diagnosis	Age (years)	Gender	Prior induction attempts	Clinical history	Response
1	1	DS-AML	2.3	Male	1	On-therapy relapse after CR	PD
2	1	AML	15.8	Male	1	Off-therapy relapse	PD
3	1	T-cell ALL (post B-precursor ALL)	18.2	Female	3	Third bone marrow relapse	CR
4	2	AML	5.2	Male	1	Refractory to induction	PD
6	2	Biphenotypic	6.9	Female	3	On-therapy relapse after CR	PD
7	2	B-precursor ALL	20.3	Male	5	Initial disease refractory to chemotherapy, relapsed post-BMT	PD
8	2	AML	11.2	Male	2	Refractory to induction	PD
9	2	B-precursor ALL	13.2	Female	3	Second off-therapy relapse; refractory to reinduction	CR
10	3	AML	10	Male	1	On-therapy relapse after CR	PD
11	3	AML	17.6	Male	1	Off-therapy relapse	PD
12	3	AML	6.7	Male	1	Refractory to induction	PD
13	3	B-precursor ALL	8.5	Male	3	Second off-therapy relapse; s/p HSCT	Not evaluable; death at day 17 from sepsis
14	3	AML	9.3	Female	3	Second off-therapy relapse; s/p HSCT	PD
15	3	B-precursor ALL	9.4	Male	2	Second off-therapy relapse; s/p HSCT	CR
16	4	B-precursor ALL	11.1	Male	2	Refractory to induction	PD
17	4	AML	10.9	Male	1	Off-therapy relapse; s/p HSCT	PD
18	4	AML	12.6	Male	4	Refractory to induction	PR
19	4	B-precursor ALL	7.4	Female	2	On-therapy relapse after CR	PD
20	4	B-precursor ALL	4.6	Male	6	On-therapy relapse followed by HSCT; relapse after HSCT, refractory to reinduction	PD
21	4	AML	3.7	Male	1	On-therapy relapse after CR	Not evaluable; study drug not given due to high bilirubin
22	4	tAML (post JMML)	13	Male	1	N/A	PR
23	4	B-precursor ALL	4.3	Male	2	On-therapy relapse after CR; refractory to reinduction	PD

Abbreviations: AML, acute myeloid leukemia; ALL, acute lymphoblastic leukemia; CR, complete response; DS, Down syndrome; HSCT, hematopoeitic stem cell transplant; JMML, juvenile myelomonocytic leukemia; PR, partial response; PD, progressive disease; tAML, therapy-related AML