A Pilot Phase II Trial of a Synthetic Tumor-Specific Breakpoint Peptide Vaccine in Patients With Chronic Myeloid Leukemia (CML) and Minimal Residual Disease

The goal of this clinical research study is to learn if giving 1 of 2 CML (Chronic Myeloid Leukemia) vaccines (CML-VAX B2 or CML-VAX B3) together with imatinib mesylate can decrease or eliminate all evidence of disease in patients who have CML that is in remission after treatment with imatinib mesylate, but who still have small amounts of detectable disease.

开始日期2005-12-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

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100 项与 Synthetic Tumor-Specific Breakpoint Peptide Vaccine(BreakThrough Therapeutics) 相关的临床结果

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100 项与 Synthetic Tumor-Specific Breakpoint Peptide Vaccine(BreakThrough Therapeutics) 相关的转化医学

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100 项与 Synthetic Tumor-Specific Breakpoint Peptide Vaccine(BreakThrough Therapeutics) 相关的专利（医药）

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项与 Synthetic Tumor-Specific Breakpoint Peptide Vaccine(BreakThrough Therapeutics) 相关的文献（医药）

2009-09-01·Cancer1区 · 医学

Synthetic tumor‐specific breakpoint peptide vaccine in patients with chronic myeloid leukemia and minimal residual disease

1区 · 医学

Article

作者: David A. Scheinberg ; Changping Li ; Nitin Jain ; James M. Reuben ; Jorge E Cortes ; Theresa Ebarb ; Hagop M Kantarjian ; Evan Cohen ; Hui Gao ; Bang Ning Lee

AbstractBACKGROUND:Imatinib is the current standard frontline therapy for chronic myelogenous leukemia (CML). In the majority of patients, imatinib induces a complete cytogenetic response (CCyR); however, complete molecular responses are infrequent. The Bcr‐Abl fusion creates a unique sequence of amino acids that could constitute a target for immunomodulation.METHODS:A mixture of heteroclitic and native peptides derived from both b3a2 and b2a2 sequences was used to vaccinate patients with CML in CCyR who were receiving imatinib therapy and who had stable Bcr‐Abl transcript levels.RESULTS:Ten patients were enrolled, all with b2a2 transcripts (including 2 patients who had coexpression of b2a2 and b3a2). Patients had received imatinib for a median of 62 months. Three of 10 patients achieved 1‐log reduction in Bcr‐Abl transcript levels, including the 2 patients who had received previous interferon therapy, and 3 other patients achieved a major molecular response. The vaccine was tolerated well, and there were no grade ≥3 adverse events. Vaccination did not affect the leukocyte profiles in peripheral blood except for regulatory T cells, which were down‐regulated briefly during the late stage of vaccination in patients who achieved approximately 1‐log reduction in Bcr‐Abl transcript levels.CONCLUSIONS:The current data suggested that vaccination‐related transient disruption of immune tolerance may contribute to the reduction in Bcr‐Abl transcripts. Clinically, this Bcr‐Abl peptide vaccine may transiently improve the molecular response in a subset of patients with CML. Cancer 2009. © 2009 American Cancer Society.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
慢性期慢性髓性白血病	临床2期	美国	Breakthrough Therapeutics LLC	2005-12-01
残留肿瘤	临床2期	美国	Breakthrough Therapeutics LLC	2005-12-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00267085 (CTgov)	临床2期	慢性期慢性髓性白血病 \| 残留肿瘤	11	Synthetic Tumor-Specific Breakpoint Peptide Vaccine	鹽繭壓醖顧範壓淵窪積(遞衊積壓遞繭鏇淵蓋獵) = 廠壓遞製醖蓋鏇廠衊醖淵鹽衊膚鏇窪鑰繭齋製 (網遞鏇積鹽憲製淵鏇顧, 鏇築夢選觸夢觸範蓋餘 ~ 醖憲鏇顧積糧鑰鬱鏇選) 更多	-	2011-02-25