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Active Not Recruiting NCT01430390

In Vitro Expanded Allogeneic Epstein-Barr Virus Specific Cytotoxic T-Lymphocytes (EBV-CTLs) Genetically Targeted to the CD19 Antigen in B-cell Malignancies

Conditions: Acute Lymphocytic Leukemia, Lymphoma

Sex: All
Healthy volunteers: No
Phase: PHASE1
Enrollment: 19
Sponsor: Memorial Sloan Kettering Cancer Center

Location: Memorial Sloan Kettering Cancer Center New York New York

Summary

The purpose of this study is to test the safety of giving the patient special cells from a donor called "Modified T-cells". The goal is to assess the toxicities of T-cells for patients with relapsed B cell leukemia or lymphoma after a blood SCT organ SCT or for patients who are at high risk for relapse of their B cell leukemia or lymphoma.

Eligibility Criteria

Inclusion Criteria: * History of CD19+ relapse/refractory (R/R) B cell malignancies occurring after allogeneic/autologous HSCT or solid organ transplant (SOT. (cohort 1) * Relapse on this protocol is detection of CD19+ malignancies in bone marrow morphology ≥ 5% any extramedullary lesion (radiographic), or detection of any disease level by cytogenetics, molecular, and/or flow cytometry. * History of relapsed or refractory CD19+ malignancies (e.g. Non Hodgkin Lymphoma) or considered high risk for relapse and and require autologous or allogeneic hematopoietic stem cell transplant (HSCT). Evidence of disease not required. (cohort 2 and 3) * No age restriction for patients * KPS or Lansky score \> or = to 50 * Renal function (measured prior to conditioning chemotherapy) * Creatinine ≤ 2.0mg/dL for patients over 18 years of ≤ 2.5 x institutional ULN for age. * Hepatic function (measured prior to conditioning chemotherapy): * AST ≤ 5 x the institutional ULN Elevation secondary to leukemic involvement is not an exclusion criterion. Leukemic involvement will be determined by the presence of progressive relapse defined by escalating bone marrow or peripheral blood leukemia blasts within the previous month and the absence of initiation of know hepatotoxic medication (e.g. azoles). * Total bilirubin ≤ 2.5 x the institutional ULN * Adequate cardiac function (e.g. LVEF ≥ 40%) as assessed by ECHO or MUGA or other similar cardia imaging performed within 1 month of treatment. * Pulmonary function (measured prior to treatment): * Oxygen saturation ≥ 90% on room air Donor Eligibility: * The patient's HSCT donor, or if HSCT donor is not available a third party donor, must consent to a leukapheresis or whole blood donation(s) obtained at one or more phlebotomies which, in aggregate, will total approximately 250 ml for adults and no more than 5ml/kg per draw from pediatric donors. * Related donors \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT01430390). StuddyBuddy aggregates publicly available trial information.