Back to resultsSalvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma (HNJ-NKAES-2012)
Primary Purpose
Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma
Status
Terminated
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Expanded haploidentical natural killer cells (NKAEs)
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma focused on measuring Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells
Eligibility Criteria
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
Sites / Locations
- Pediatric Hematology-Oncology; Hospital Infantil Universitario La Paz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Activated natural killer cells
Arm Description
Activated natural killer cells
Outcomes
Primary Outcome Measures
Safety profile (number of AEs per patient)
Secondary Outcome Measures
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
time to hematological recovery (days)
hematological recovery: neutrophils >500/mm3, lymphocytes >250/mm3 and platelets >50.000/mm3)
days of hospitalization in each cycle
Objective response rate
Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR)
days of isolation
Full Information
NCT ID
NCT01944982
First Posted
September 13, 2013
Last Updated
December 19, 2016
Sponsor
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
1. Study Identification
Unique Protocol Identification Number
NCT01944982
Brief Title
Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma
Acronym
HNJ-NKAES-2012
Official Title
Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
The low recruitment rate makes it very difficult to complete the study within a reasonable period of time.
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma
Keywords
Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activated natural killer cells
Arm Type
Experimental
Arm Description
Activated natural killer cells
Intervention Type
Biological
Intervention Name(s)
Expanded haploidentical natural killer cells (NKAEs)
Primary Outcome Measure Information:
Title
Safety profile (number of AEs per patient)
Time Frame
Two months
Secondary Outcome Measure Information:
Title
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
Time Frame
During 14 months
Title
time to hematological recovery (days)
Description
hematological recovery: neutrophils >500/mm3, lymphocytes >250/mm3 and platelets >50.000/mm3)
Time Frame
2 months
Title
days of hospitalization in each cycle
Time Frame
2 months
Title
Objective response rate
Description
Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR)
Time Frame
2 months
Title
days of isolation
Time Frame
2 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Pérez-Martínez, MD, PhD
Organizational Affiliation
Service of Pediatric Hematology-Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Hematology-Oncology; Hospital Infantil Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
29477379
Citation
Vela M, Corral D, Carrasco P, Fernandez L, Valentin J, Gonzalez B, Escudero A, Balas A, de Paz R, Torres J, Leivas A, Martinez-Lopez J, Perez-Martinez A. Haploidentical IL-15/41BBL activated and expanded natural killer cell infusion therapy after salvage chemotherapy in children with relapsed and refractory leukemia. Cancer Lett. 2018 May 28;422:107-117. doi: 10.1016/j.canlet.2018.02.033. Epub 2018 Feb 23.
Results Reference
derived
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Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma
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