Last updated on June 2020

Leukapheresis for CAR-Therapy Manufacturing


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphocytic Leukemia | Acute | childhood ALL | Non-Hodgkin's Lymphoma | Lymphoproliferative Disorder | Leukemia (Pediatric) | Lymphoma | leukemia | Lymphoproliferative disorders | Diffuse Large B-Cell Lymphoma
  • Age: Between 3 - 30 Years
  • Gender: Male or Female

  • INCLUSION CRITERIA:
    • Age: greater than or equal to 3 and less than or equal to 30 years
    • Weight greater than or equal to 15 kg
    • Confirmation of leukemia or lymphoma diagnosis provided by prior flow cytometry, PCR or H&E verification.
    • Disease Status:
    • Relapsed/refractory leukemia or lymphoma that has failed one standard and one salvage therapy and are not in remission at the time of leukapheresis, OR
    • Previously treated patients without detectable disease at the time of leukapheresis but at high-relapse risk.
    • Potentially eligible for future NIH-CAR therapy based on the following:
    • Adequate performance status: Patients > 10 years of age: Karnofsky greater than or equal to 50%; Patients less than or equal to 10 years of age: Lansky scale greater than or equal to 50%
    • Adequate organ function:
    • absolute neutrophil count >750/mcL*
    • platelets greater than or equal to 30,000/mcL*
    • total bilirubin less than or equal to 2 X ULN (except in the case of subjects with documented Gilbert s disease > 3x ULN)

AST(SGOT)/ALT(SGPT) less than or equal to 20 X institutional upper limit of normal for age and laboratory normal ranges

creatinine within age adjusted normal institutional limits (see table below)

OR

creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

  • Age less than or equal to 5 years- Maximun serum creatinine of 0.8
  • Age less than or equal to 10 and greater than 5 years- Maximun serum creatinine of 1.0
  • Age greater than 10 years- Maximun serum creatinine of 0.8
  • Cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion.
  • Patients, parents/guardian(s), legally authorized representative (LAR), or durable power of attorney must be able to give consent and sign the informed consent document.

EXCLUSION CRITERIA:

  • Transfusion refractory thrombocytopenia such that platelet count cannot be adequately supported with transfusions to be maintained greater than or equal to 30,000/mcL
  • Active DIC, bleeding or coagulopathy which cannot be corrected with minimal intervention
  • Rapidly progressive disease or hyperleukocytosis greater than or equal to 50,000 blasts/mcL
  • Symptomatic, uncontrolled or severe intercurrent illness that would compromise the ability to tolerate CAR therapy based toxicity
  • Systemic chemotherapy less than or equal to 2 weeks (6 weeks for clofarabine or nitrosoureas) or radiation therapy less than or equal to 3 weeks prior to leukapheresis; with the following exception

--Maintenance chemotherapy including tyrosine kinase inhibitors will be allowed up to one week prior to apheresis (there will be no wash-out required for steroids).

  • Other anti-neoplastic investigational agents, or antibody-based therapies currently or within 2 weeks prior to leukapheresis (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 therapyrelated are exempt from this exclusion.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at screening
  • Active or latent hepatitis B or active hepatitis C, or any uncontrolled infection at screening
  • Human Immunodeficiency Virus (HIV) infection at screening (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities)
  • Any patient that in the opinion of the investigator is not medically stable to undergo the leukapheresis procedure or will not comply with the visit schedules or procedures

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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