Relapsed/Refractory Paediatric Acute LeukaemiaPhase 2LYDIANCT02074657
"LANK-2": Activated and Expanded NK Cell Immunotherapy Together With Salvage Chemotherapy in Children, Adolescents and Young Adults With Relapsed or Refractary Acute Leukemia
A Phase 2 study testing Activated and expanded natural killer cells (NKAEs) in people with Relapsed/Refractory Paediatric Acute Leukaemia, run by Hospital Universitario La Paz at 2 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages Up to 23 years
- Conditions the study is for
- Relapsed/Refractory Paediatric Acute Leukaemia
- What is being tested?
- Activated and expanded natural killer cells (NKAEs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesSpain
- Study dates
- Apr 2014to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- Patients with history of bad therapeutical compliance
- Patients not valid after psycho-social evaluation
- Positive HIV serology
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital 12 de Octubre
Madrid, Madrid, 28041
Hospital Infantil Universitario La Paz
Madrid, Madrid, 28046
About this study
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
- Being tested
- Activated and expanded natural killer cells (NKAEs)
- Keywords
- Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated and expanded natural killer cells (NKAEs)Biological
Activated and expanded natural killer cells (NKAEs) from haploidentical donor
| Study group | Role | What they receive |
|---|---|---|
| Activated natural killer cells | Experimental | Not described Receives: Biological: Activated and expanded natural killer cells (NKAEs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months after infusion
Secondary outcomes (4)
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
Measured: End of infusion and follow-up (2 months and 1 year)
Days of hematological recovery (neutrophils >500/microL, lymphocytes >250/microL and platelets >50.000/microL), days of hospitalization, in each cycle Immune
Measured: End of infusion and follow-up (2 months and 1 year)
Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment
Measured: End of infusion and follow-up (2 months and 1 year)
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.
Measured: End of infusion and follow-up (2 months and 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory Paediatric Acute LeukaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Pérez Martínez, Hospital Universitario La Paz
- Investigators
- Antonio Pérez-Martínez, MD, PhD, Study chair, Hospital Infantil Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074657
- Sponsor's protocol ID
- 2012-005146-38
- Acronym
- LYDIA
- Status last verified
- Dec 2016
- First submitted
- 26 Feb 2014
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29477379
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02074657
- Acronym / sponsor ID
- LYDIA / 2012-005146-38
- Keywords
- Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activated natural killer cells | Experimental | Biological: Activated and expanded natural killer cells (NKAEs) |
Who may qualify
- Ages
- Up to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (3 listed)
- Patients with history of bad therapeutical compliance
- Patients not valid after psycho-social evaluation
- Positive HIV serology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activated and expanded natural killer cells (NKAEs)Activated and expanded natural killer cells (NKAEs) from haploidentical donor | Biological | Activated natural killer cells |
Primary outcome
To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia
Time frame: 2 months after infusion
Number of patients with adverse events according to NCI-CTCAE v4.0 CRITERIA as a measure of safety and tolerability
4 secondary outcomes
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Derived from this study: PubMed 29477379Vela 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.
Related trials for Relapsed/Refractory Paediatric Acute Leukaemia
RecruitingPhase 1/2
Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)
Acute Lymphoblastic Leukemia, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Pérez-Martínez, MD, PhD study chair
Hospital Infantil Universitario La Paz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Activated and expanded natural killer cells (NKAEs) in people with Relapsed/Refractory Paediatric Acute Leukaemia, run by Hospital Universitario La Paz at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety of activated and expanded NK cell (NKAE) immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute leukemia (time frame: 2 months after infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02074657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.