Anti-CD19 White Blood Cells for Children and Young Adults With B Cell Leukemia or Lymphoma

Completed · Phase 1

Conditions studied: ALL, B Cell Lymphoma, Leukemia, Large Cell Lymphoma, Non-Hodgkin Lymphoma

In brief

Background: \- Although progress has been made in treating children with B-cell cancers such as leukemia or lymphoma, many children do not respond to the standard treatments. One possible treatment involves collecting white blood cells called T cells from the person with cancer and modifying the cells to attack the B-cell cancer. The cells can then be given back to the participant. This study will use T cells that have been modified to attack the cluster of differentiation 19 (CD19) protein, which is found on the surface of some B-cell cancers. Objectives: \- To see if anti-CD19 modified white blood cells are a safe and effective treatment for children and young adults with advanced B-cell cancer. Eligibility: * Children and young adults between 1 and 30 years of age who have B-cell cancer (leukemia or lymphoma) that has not responded to standard treatments. * The leukemia or the lymphoma must have the CD19 protein. * There must be adequate organ function. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies or bone marrow biopsies may be performed depending on the type of cancer. * Participants will undergo a process where white blood cells are collected, called apheresis. These cells will be modified to contain the anti-CD19 gene. * Participants will have 3 days of chemotherapy to prepare their immune system to accept the modified cells. * Participants will receive an infusion of their own modified white blood cells. They will remain in the hospital until they have recovered from the treatment. * Participants will have frequent follow-up visits to monitor the outcome of the treatment. * If the participant benefits from the treatment, then he/she may have the option for another round of treatment.

Key facts

Study ID: NCT01593696
Run by: National Cancer Institute (NCI)
People needed: 53
Starts: 2012-06-29
Expected to finish: 2017-10-02
Last updated by the study team: 2020-08-31

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Subjects meeting any of the following criteria are not eligible for participation in the study:
Recurrent or refractory ALL limited to isolated testicular disease.
Hepatic function: Inadequate liver function defined as total bilirubin > 2x upper limit of normal (ULN) (except in the case of subjects with documented Gilbert's disease > 3x ULN) or transaminase (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 20x ULN based on age and laboratory specific normal ranges;
Renal function: Greater than age-adjusted normal serum creatinine (see below) and a creatinine clearance < 60 mL/min/1.73 m\^2.
Age:
<= 5 yrs (Maximum Serum Creatinine = 0.8 mg/dL)
5 < age <=10 yrs (Maximum Serum Creatinine =1.0 mg/dL)
> 10 yrs (Maximum Serum Creatinine = 1.2 mg/dL)
Hematologic function:
Absolute neutrophil count (ANC) < 750/microliter, or platelet count < 50,000/microliter, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy);
A subject will not be excluded because of pancytopenia greater than or equal to Grade 3 if it is due to disease, based on the results of bone marrow studies.
Hyperleukocytosis (greater than or equal to 50,000 blasts/microliter) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
Pregnant or breast-feeding females;
Recent prior therapy:
Systemic chemotherapy less than or equal to 2 weeks (6 weeks for nitrosoureas) or radiation therapy less than or equal to 3 weeks prior to apheresis;
Exceptions:
There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such;
Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis;
Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study provided they meet all other eligibility criteria;
Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis;
For radiation therapy: Radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable/evaluable disease outside the radiation port.
Other anti-neoplastic investigational agents currently or within 30 days prior to apheresis (i.e. start of protocol therapy);
Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met. Cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion.
Human immunodeficiency virus/hepatitis B virus/Hepatitis C virus (HIV/HBV/HCV) Infection:
Seropositive for HIV antibody. (Patients with HIV are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy in the future should study results indicate effectiveness.)

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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