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.

Start Date01 Dec 2005

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

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100 Clinical Results associated with Synthetic Tumor-Specific Breakpoint Peptide Vaccine(BreakThrough Therapeutics)

100 Translational Medicine associated with Synthetic Tumor-Specific Breakpoint Peptide Vaccine(BreakThrough Therapeutics)

100 Patents (Medical) associated with Synthetic Tumor-Specific Breakpoint Peptide Vaccine(BreakThrough Therapeutics)

Literatures (Medical) associated with Synthetic Tumor-Specific Breakpoint Peptide Vaccine(BreakThrough Therapeutics)

01 Sep 2009·CancerQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: 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.

100 Deals associated with Synthetic Tumor-Specific Breakpoint Peptide Vaccine(BreakThrough Therapeutics)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic phase chronic myeloid leukemia	Phase 2	US	Breakthrough Therapeutics LLC	01 Dec 2005
Residual Neoplasm	Phase 2	US	Breakthrough Therapeutics LLC	01 Dec 2005

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00267085 (CTgov)	Phase 2	Chronic phase chronic myeloid leukemia \| Residual Neoplasm	11	Synthetic Tumor-Specific Breakpoint Peptide Vaccine	pzxvpnhifg(qfkfwtnccc) = tzflhkhobd gghineymot (eyibprynox, gfpjaknbnw - gcaixelxio) View more	-	25 Feb 2011

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