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Clinical Trial 20543

Cancer Type: Immunotherapy
Study Type: Other
NCT#: NCT02735083

Phase: N/A
Prinicipal Investigator: Frederick Locke

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Overview

Study Title

Long-term Follow-Up Study of Patients Who Have Previously Been Exposed to UCART19/ALLO-501 (Allogeneic Engineered T-Cells Expressing a Lentiviral-Based Anti-CD19 Chimeric Antigen Receptor)

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of UCART19/ALLO-501 administration to patients with advanced lymphoid malignancies.

Objective

Primary Objective: To evaluate the long-term safety of patients with advanced lymphoid malignancies who have been previously administered with UCART19/ALLO-501 following lymphodepletion with fludarabine and cyclophosphamide with or without alemtuzumab or ALLO-647. Secondary Objectives: -to assess long-term anti tumor activity (progression-free survival, disease specific survival) -for those patients treated with UCART19, assess the proportion of patients who underwent aloogeneic HSCT -for those patients treated with UCART19, assess the time to transplant -to assess overall survival -to monitor the long-term persistence of UCART19/ALLO-501 in blood -to monitor the long-term persistence of UCART19/ALLO-501 in the bone marrow (only in bone marrow samples performed as part of routine care and at the Investigator's discretion) -to evaluate immunogenicity against ALLO-647 in patients who have received ALLO-647 Exploratory Objectives -to monitor the absence of replication competent lentivirus (RCL) -to investigate the potential development of an anti-UCART19/ALLO-501 immune response -to perform a retrospective genomic analysis, in case a T-cell transformation is observed

Treatments

Therapies

Medications

Inclusion Criteria

> Inclusion Criteria:>

  • Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative)
  • Patient dosed with UCART19/ALLO-501 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19/ALLO-501, or patients who were administered UCART19/ALLO-501 under a special access scheme (compassionate use);
  • Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners.

  • Exclusion Criteria

    >Exclusion Criteria:>

  • No exclusion criteria for this study

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