In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 6537-6537
Abstract:
6537 Background: CAYA with ALL or AML in third complete remission (CR3), refractory relapse (RR) or induction failure (IF) have an extremely poor prognosis, 〈 20% EFS (Gaynon, BJH, 2005;Wells, JCO, 2003). CLO, an inhibitor of DNA polymerase and ribonucleotide reductase, has significant activity in CAYA with relapsed ALL/AML (Jeha, JCO 2006,2009) and synergy with cytarabine (Faderl, Blood, 2005). We sought to determine safety, day-100 TRM, and overall survival (OS) associated with CLO, cytarabine and TBI followed by AlloSCT in CAYA with poor-risk ALL/AML. Methods: This is a multi-center phase I/II trial of a novel conditioning regimen of CLO (dose escalation: 40mg/m 2 [n=3], 46 mg/m 2 [n=3], 52 mg/m 2 [n=19]) x5d, sequential (4 hrs later) cytarabine 1000 mg/m 2 x6d and TBI (1200cGy) followed by AlloSCT from matched related or unrelated donors in CAYA with ALL/AML in CR3, RR or IF. Patients with unrelated donors received R-ATG. GVHD prophylaxis consisted of tacrolimus and MMF (Bhatia/Cairo, BBMT, 2009). Kaplan-Meier method was used to determine the probabilities of engraftment, GVHD, TRM and OS. Results: 25 pts, median age: 11.3 yrs (1.5-20.7); M:F: 19:6, ALL/AML: 22:3 (10 CR3, 3 RR, 12 IF), 10 related donors, 15 unrelated donors (9 BM/PBSCs, 6 UCB). Median TNC and CD34 dose was 4.47x10 8 /kg and 4.84x10 6 /kg for BM/PBSCs and 4.0x10 7 /kg and 2.8x10 5 /kg for UCB, respectively. Probabilities of neutrophil, platelet engraftment and grade II-IV aGVHD were 100%, 92.9% and 47.5%, respectively. CLO dose was tolerable at 52mg/m 2 /d x5d without dose limiting toxicity. Probability of Day 100 TRM was only 4.3%. Probability of 1-yr PFS and OS were 51% (CI 95 : 28-71%), and 43% (CI 95 : 22-63%) respectively. Conclusions: Preliminary results suggest this novel regimen followed by AlloSCT is safe and well tolerated in CAYA with poor-risk ALL/ AML with CLO dose 52 mg/m 2 . Results are encouraging with respect to low risk of day 100 TRM and leukemic relapse associated with this conditioning regimen in this poor-risk population.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.6537
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
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