Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma

Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma Clinical Trial

— HNJ-NKAES-2012  

Official title:

Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01944982
• Other study ID #: HNJ-NKAES-2012
• Secondary ID: 2012-000054-63
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 13, 2013
• Last updated: December 19, 2016
• Start date: July 2013
• Est. completion date: September 2016

Study information

• Verified date: December 2016
• Source: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma

Intervention

Biological:
• Expanded haploidentical natural killer cells (NKAEs)

Locations

Country	Name	City	State
Spain	Pediatric Hematology-Oncology; Hospital Infantil Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile (number of AEs per patient)		Two months	Yes
Secondary	Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections		During 14 months	Yes
Secondary	time to hematological recovery (days)	hematological recovery: neutrophils >500/mm3, lymphocytes >250/mm3 and platelets >50.000/mm3)	2 months	Yes
Secondary	days of hospitalization in each cycle		2 months	Yes
Secondary	Objective response rate	Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR)	2 months	No
Secondary	days of isolation		2 months	No