Back to results"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia (LYDIA)
Primary Purpose
Relapsed/Refractory Paediatric Acute Leukaemia
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Activated and expanded natural killer cells (NKAEs)
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Paediatric Acute Leukaemia focused on measuring Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells
Eligibility Criteria
Inclusion Criteria:
- Patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or
- Patients between 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion criteria 1 or 2)
- Lansky index > 60%
- Mild (<2) functional organs alteration (hepatic, renal, respiratory) according to National Cancer Institute criteria (NCI CTCAE v4).
- Left ventricular ejection fraction > 39%
- To grant informed consent in accordance with the current legal regulations.
- Presence of a compatible haploidentical donor (father or mother or brother).
Exclusion Criteria:
- Patients with history of bad therapeutical compliance
- Patients not valid after psycho-social evaluation
- Positive HIV serology
Sites / Locations
- Hospital 12 de Octubre
- Hospital Infantil Universitario La Paz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Activated natural killer cells
Arm Description
Outcomes
Primary Outcome Measures
To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia
Number of patients with adverse events according to NCI-CTCAE v4.0 CRITERIA as a measure of safety and tolerability
Secondary Outcome Measures
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
Days of hematological recovery (neutrophils >500/microL, lymphocytes >250/microL and platelets >50.000/microL), days of hospitalization, in each cycle Immune
Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment
Immune reconstitution: Median of T-cell , B, NK, Natural Killer T cell (NKT) and dendritic cells count and subpopulations of T and NK lymphocytes (cel/microL) during posttreatment follow-up period.
Full Information
NCT ID
NCT02074657
First Posted
February 26, 2014
Last Updated
December 19, 2016
Sponsor
Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT02074657
Brief Title
"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia
Acronym
LYDIA
Official Title
"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (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 Universitario La Paz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine safety profile of immunotherapy with natural killer cells and activated expanded (NKAEs) after salvage chemotherapy in children, adolescents and young adults with relapsed or refractary acute leukemia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Paediatric Acute Leukaemia
Keywords
Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activated natural killer cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Activated and expanded natural killer cells (NKAEs)
Intervention Description
Activated and expanded natural killer cells (NKAEs) from haploidentical donor
Primary Outcome Measure Information:
Title
To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia
Description
Number of patients with adverse events according to NCI-CTCAE v4.0 CRITERIA as a measure of safety and tolerability
Time Frame
2 months after infusion
Secondary Outcome Measure Information:
Title
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
Time Frame
End of infusion and follow-up (2 months and 1 year)
Title
Days of hematological recovery (neutrophils >500/microL, lymphocytes >250/microL and platelets >50.000/microL), days of hospitalization, in each cycle Immune
Time Frame
End of infusion and follow-up (2 months and 1 year)
Title
Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment
Time Frame
End of infusion and follow-up (2 months and 1 year)
Title
Immune reconstitution: Median of T-cell , B, NK, Natural Killer T cell (NKT) and dendritic cells count and subpopulations of T and NK lymphocytes (cel/microL) during posttreatment follow-up period.
Time Frame
End of infusion and follow-up (2 months and 1 year)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or
Patients between 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion criteria 1 or 2)
Lansky index > 60%
Mild (<2) functional organs alteration (hepatic, renal, respiratory) according to National Cancer Institute criteria (NCI CTCAE v4).
Left ventricular ejection fraction > 39%
To grant informed consent in accordance with the current legal regulations.
Presence of a compatible haploidentical donor (father or mother or brother).
Exclusion Criteria:
Patients with history of bad therapeutical compliance
Patients not valid after psycho-social evaluation
Positive HIV serology
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Pérez-Martínez, MD, PhD
Organizational Affiliation
Hospital Infantil Universitario La Paz
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
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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"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia
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