Leukapheresis for CAR or Adoptive Cell Therapy Manufacturing

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

Observacional

Fase

No aplica / no indicada

Rango de edad

3 años - 65 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

120 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

Background:

Leukapheresis is a procedure to separate and collect white blood cells. It is the first step in a treatment called CAR (chimeric antigen receptor) T-cell therapy. CAR-T therapy may be offered to people when their cancer comes back. The collected T-cells are used to make a special version of T-cells called CARs. Researchers want to collect these cells from people who may become eligible for a CAR T-cell study in the future.

Objective:

To identify people who have a high likelihood to benefit from CAR T-cell therapy early in their disease course and collect and store a T-cell product.

Eligibility:

People ages 3-65 with a form of leukemia or lymphoma that has not been cured by standard therapy

Design:

Participants will be screened with medical history, physical exam, and blood and urine tests. Review of existing MRI, x-ray, pathology specimens/reports or CT images may be done.

On this study, participants will have leukapheresis. A needle will be placed into the arm. Blood will be collected and go through a machine. White blood cells will be taken out by the machine. The plasma and red cells will be returned to the participant through a second needle in the other arm. The procedure will take 4-6 hours. Some participants may have a central line (catheter) inserted which is needed to do the leukapheresis procedure, instead of the needles in the arms-especially if they are smaller. For a central line placement, a long thin tube is inserted through a small incision into the main blood vessel leading into the heart that would allow access to the blood to do the leukapheresis procedure.

Participants cells will be processed and frozen for future use in a CAR T-cell therapy study.

...

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

• INCLUSION CRITERIA:
• Age: \>= 3 and \<= 65 years
• Weight \>= 15 kg
• Confirmation of cancer diagnosis provided by disease-specific assessment (e.g., flow cytometry, PCR) or H\&E verification.
• Disease Status:

• Relapsed/refractory cancer that has failed at least one standard regimen 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 or other adoptive cell therapy based on the following:

• Adequate performance status: Patients \> 10 years of age: Karnofsky \>= 50%; Patients \<= 10 years of age: Lansky scale \>= 50%
• Adequate organ function:

• absolute neutrophil count \>750/mcL\*
• platelets \>=30,000/mcL\*
• total bilirubin \<=2 X ULN (except in the case of subjects with documented Gilbert s disease \> 3x ULN)

AST(SGOT)/ALT(SGPT)\<=20 X institutional upper limit of normal for age and laboratory normal ranges

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

creatinine clearance \>= 60 mL/min/1.73 m\^2 for creatinine levels above institutional normal.

• Age (Years): \<=5; Maximum Serum Creatine (mg/dL): 0.8
• Age (Years): 5 \< age \<= 10; Maximum Serum Creatine (mg/dL): 1.0
• Age (Years): \>10; Maximum Serum Creatine (mg/dL): 1.2

• Cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion.

• Patients, parents/guardians, 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 at \>=30,000/mcL
• Active DIC, bleeding or coagulopathy which cannot be corrected with minimal intervention
• Rapidly progressive disease or hyperleukocytosis \>= 50,000 blasts/mcL
• Symptomatic, uncontrolled or severe intercurrent illness that would compromise the ability to tolerate CAR or adoptive cell therapy-based toxicity
• 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) individuals, where pregnancy is defined as the state of 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

Población del estudio

Patients 3-65 years of age, at least 15 kg, with relapsed/refractory cancer that has recurred after or not responded to one or more standard regimens and/or deemed incurable by standard therapy and who meet all eligibility criteria are eligible to participate.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No informado

Enmascaramiento

No informado

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Equipo y fechas

Patrocinador principal

National Cancer Institute (NCI)

Inicio del estudio

14 ago 2017 Real

Finalización primaria

31 ene 2030 Estimado

Finalización del estudio

31 jul 2030 Estimado

Primera publicación

24 jul 2017 Real

Última actualización

9 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.