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

Phase 1

Terminated

• Conditions: Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma
• Interventions: Biological: Expanded haploidentical natural killer cells (NKAEs)

• Registration Number: NCT01944982
• Lead Sponsor: Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-18
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Activated natural killer cells	Expanded haploidentical natural killer cells (NKAEs)	Activated natural killer cells

Primary Outcome Measures

Name	Time	Method
Safety profile (number of AEs per patient)	Two months

Secondary Outcome Measures

Name	Time	Method
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections	During 14 months
time to hematological recovery (days)	2 months	hematological recovery: neutrophils \>500/mm3, lymphocytes \>250/mm3 and platelets \>50.000/mm3)
days of hospitalization in each cycle	2 months
Objective response rate	2 months	Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR)
days of isolation	2 months

Trial Locations

Locations (1)

Pediatric Hematology-Oncology; Hospital Infantil Universitario La Paz; 🇪🇸 Madrid, Spain