Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma (HNJ-NKAES-2012)

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma

Treatments: Biological: Expanded haploidentical natural killer cells (NKAEs)

Study type: Interventional

Funder types: Other

Identifiers

NCT01944982

HNJ-NKAES-2012

2012-000054-63 (EudraCT Number)

Details and patient eligibility

About

To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.

Enrollment: 7 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged between 0 and 21 years with relapsed or refractary acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
• Lansky Index > 60%.
• Left ventricular ejection fraction > 39%.
• Negative HIV serology.
• Provide informed consent in accordance with current legislation.

Exclusion criteria

• Patients with a history of poor compliance.
• Patients not valid after psycho-social evaluation
• Severe (4) functional organ disorders (hepatic, renal, respiratory) according to NCI CTCAE v3 criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Activated natural killer cells

Experimental group

Description:

Activated natural killer cells

Treatment:

Biological: Expanded haploidentical natural killer cells (NKAEs)