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Trial record 17 of 50238 for:    will | Recruiting, Not yet recruiting, Available Studies

Peptide-drug-conjugates for Personalized, Targeted Therapy of Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT02828774
Recruitment Status : Not yet recruiting
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
shpilberg ofer, Assuta Medical Center

Brief Summary:
Using phage libraries extensively pre-absorbed on a series of normal cell types, we will isolate phage specifically internalized by B-CLL cells from newly diagnosed and untreated CLL patients. Peptide sequences are then derived by Next Generation Sequencing (NGS). NGS-based studies are contributing to an improved understanding of cancer heterogeneity in order to tailor treatment to patients based on the individual makeup of their tumor. However the use of NGS to derive phage displayed peptide sequences is so far rare (22). Traditionally, after exposure to a target and recovery by elution, the phage clones are isolated by titration on bacterial lawns. It is technically demanding and labour intensive to select and analyze more than about 15 of the sometimes thousands clones recovered. Therefore information on other potentially important sequences is missed. NGS allows sequencing of the entire recovered phage pool and provides far more detailed bioinformatic analyses of peptide sequences or motifs. RNA from the CLL cells is used for RNA-seq expression sequencing. The wide application of NGS in combination with bioinformatics tools has begun to revolutionize cancer research, diagnosis and therapy. The peptide and RNA sequencing data will afford bioinformatic testing of correlations of exome expression and clinical parameters with the pattern of peptide sequences internalized by CLL cells of different patients. This information is crucial to answering questions 1, 2 and 3 discussed on page 1 above. The results of this analysis will probably not allow identification of specific receptors targeted by the peptides. The aim at this stage of the research is to identify candidate targeting peptides. Once identified, further research will be needed to identify the receptors to which they bind. Regarding question 4, there is currently very little published information on the therapeutic potential of PDCs in leukemia. Using two peptides we have isolated that target murine A20 leukemic cells, we will prepare multi-drug PDCs (using technology we have developed) and in an animal model, test their ability to enhance the survival and quality of life of CLL bearing animals.

Condition or disease Intervention/treatment
CLL Other: there will be no intervention.

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peptide-drug-conjugates for Personalized, Targeted Therapy of Chronic Lymphocytic Leukemia
Study Start Date : August 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020



Intervention Details:
  • Other: there will be no intervention.
    this study is observational, procedure are done in vitro and on animal models.


Primary Outcome Measures :
  1. Cytotoxicity of PDCs and free drug will be assessed by calculating % Growth Inhibition of treated versus untreated cells. [ Time Frame: 36 months ]

Biospecimen Retention:   Samples Without DNA
RNA will be extracted from CLL cells in the blood.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
CLL patients
Criteria

Inclusion Criteria:

  • CLL patients intended to receive treatment in 30 days from recruitment to the study..

Exclusion Criteria:

  • CLL patient not about to receive treatment in 30 day of recruitment to the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828774


Contacts
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Contact: Ofer Shpilberg, MD +972-37644364 ofers@assuta.co.il
Contact: Noa Zifman, MSc +972-37645497 noaz@assuta.co.il

Sponsors and Collaborators
Assuta Medical Center
Investigators
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Principal Investigator: Ofer Shpilberg, MD Assuta Medical Centers

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Responsible Party: shpilberg ofer, Prof. Ofer Shpilberg, Assuta Medical Center
ClinicalTrials.gov Identifier: NCT02828774     History of Changes
Other Study ID Numbers: 2015050
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell