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An observational study of Chinese adults with relapsed/refractory Philadelphia-negative acute lymphoblastic leukemia.

ABSTRACT: Aim:Chinese adults with relapsed/refractory Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph- ALL) have poor outcomes. Patients & methods:We conducted a nationwide, retrospective, observational study to assess outcomes in this patient population. Results:Of the 270 enrolled patients, 31% of patients at last salvage achieved complete remission (CR) or CR with partial hematologic recovery (CRh), with median time to CR/CRh of 30 days and median CR/CRh duration of 2.7 months. The CR/CRh rate was more favorable with earlier versus later lines of salvage (41, 24 and 17% at first, second and third or later salvages, respectively). Conclusion:This dataset serves as an important reference of real-world outcomes using currently available chemotherapy regimens for high-risk Chinese adults with relapsed/refractory Ph- ALL.

SUBMITTER: Ma J

PROVIDER: S-EPMC6219430 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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An observational study of Chinese adults with relapsed/refractory Philadelphia-negative acute lymphoblastic leukemia.

Ma Jun J Liu Ting T Jin Jie J Hu Jianda J Liu Qifa Q Wang Jianxiang J Shen Zhixiang Z Du Xin X Jiang Bin B Meng Xianhua X

International journal of hematologic oncology 20180601 2

<h4>Aim</h4>Chinese adults with relapsed/refractory Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph- ALL) have poor outcomes.<h4>Patients & methods</h4>We conducted a nationwide, retrospective, observational study to assess outcomes in this patient population.<h4>Results</h4>Of the 270 enrolled patients, 31% of patients at last salvage achieved complete remission (CR) or CR with partial hematologic recovery (CRh), with median time to CR/CRh of 30 days and media ...[more]

PMID: 30405901

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Project description:PurposeDespite advances in immunotherapies, the prognosis for adults with Philadelphia chromosome-negative, newly diagnosed (ND) or relapsed/refractory (R/R) acute lymphoblastic leukemia/acute biphenotypic leukemia (ALL/ABL) remains poor. The benzamide derivative entinostat inhibits histone deacetylase and induces histone hyperacetylation. The purine nucleoside analogue clofarabine is FDA-approved for R/R ALL in children 1-21 years of age. Low doses of clofarabine have been reported to induce DNA hypomethylation. We conducted a phase 1 study of low dose clofarabine with escalating doses of entinostat in adults with ND or R/R ALL/ABL.Experimental designAdults ≥60 years with ND ALL/ABL or ≥21 years with R/R ALL/ABL received repeated cycles every 3 weeks of entinostat (4 mg, 6 mg or 8 mg orally days 1 and 8) and clofarabine (10 mg/m2/day IV for 5 days, days 3-7) (Arm A). Adults aged 40-59 years with ND ALL/ABL or age ≥21 years in first relapse received entinostat and clofarabine prior to traditional chemotherapy on day 11 (Arm B). Changes in DNA damage, global protein lysine acetylation, myeloid-derived suppressor cells and monocytes were measured in PBMCs before and during therapy.ResultsTwenty-eight patients were treated at three entinostat dose levels with the maximum administered dose being entinostat 8 mg. The regimen was well tolerated with infectious and metabolic derangements more common in the older population versus the younger cohort. There was no severe hyperglycemia and no peripheral neuropathy in this small study. There were 2 deaths (1 sepsis, 1 intracranial bleed). Overall response rate was 32 %; it was 50 % for ND ALL/ABL. Entinostat increased global protein acetylation and inhibited immunosuppressive monocyte subpopulations, while clofarabine induced DNA damage in all cell subsets examined.ConclusionEntinostat plus clofarabine appears to be tolerable and active in older adults with ND ALL/ABL, but less active in R/R patients. Further evaluation of this regimen in ND ALL/ABL appears warranted.

Dataset Information

An observational study of Chinese adults with relapsed/refractory Philadelphia-negative acute lymphoblastic leukemia.

Publications

An observational study of Chinese adults with relapsed/refractory Philadelphia-negative acute lymphoblastic leukemia.

Similar Datasets

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