Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and LymphomaPhase 1/2HNJ-NKAES-2012NCT01944982
Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma
A Phase 1/2 study testing Expanded haploidentical natural killer cells (NKAEs) in people with Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma, run by Hospital Infantil Universitario Niño Jesús, Madrid, Spain at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma
- What is being tested?
- Expanded haploidentical natural killer cells (NKAEs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2013to Sep 2016
- Phase
- Phase 1/2
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Pediatric Hematology-Oncology; Hospital Infantil Universitario La Paz
Madrid, Madrid, 28046
About this study
Official title: Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma.
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.
- Being tested
- Expanded haploidentical natural killer cells (NKAEs)
- Keywords
- Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells
- Medical subject headings
- Recurrence, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded haploidentical natural killer cells (NKAEs)Biological
| Study group | Role | What they receive |
|---|---|---|
| Activated natural killer cells | Experimental | Activated natural killer cells Receives: Biological: Expanded haploidentical natural killer cells (NKAEs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile (number of AEs per patient)
Measured: Two months
Secondary outcomes (5)
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
Measured: During 14 months
time to hematological recovery (days)
hematological recovery: neutrophils >500/mm3, lymphocytes >250/mm3 and platelets >50.000/mm3)
Measured: 2 months
days of hospitalization in each cycle
Measured: 2 months
Objective response rate
Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR)
Measured: 2 months
days of isolation
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: The low recruitment rate makes it very difficult to complete the study within a reasonable period of time.
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 T Cell Lymphoblastic Leukaemia and LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Perez-Martinez, Hospital Universitario La Paz
- Investigators
- Antonio Pérez-Martínez, MD, PhD, Principal investigator, Service of Pediatric Hematology-Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944982
- Sponsor's protocol ID
- HNJ-NKAES-2012
- Other IDs
- 2012-000054-63
- Acronym
- HNJ-NKAES-2012
- Status last verified
- Dec 2016
- First submitted
- 13 Sep 2013
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
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
- Salvage Therapy With Chemotherapy and Natural Killer Cells in Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma.
- ClinicalTrials.gov ID
- NCT01944982
- Acronym / sponsor ID
- HNJ-NKAES-2012 / HNJ-NKAES-2012
- Keywords
- Immunotherapy, NKAEs, Expanded haploidentical natural killer cells, Activated natural killer cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The low recruitment rate makes it very difficult to complete the study within a reasonable period of time.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hospital Infantil Universitario Niño Jesús, Madrid, SpainUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Sep 2013 (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 relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.
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: Expanded haploidentical natural killer cells (NKAEs)Activated natural killer cells |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Expanded haploidentical natural killer cells (NKAEs) | Biological | Activated natural killer cells |
Primary outcome
Safety profile (number of AEs per patient)
Time frame: Two months
5 secondary outcomes
Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
Time frame: During 14 months
time to hematological recovery (days)
Time frame: 2 months
days of hospitalization in each cycle
Time frame: 2 months
Objective response rate
Time frame: 2 months
days of isolation
Time frame: 2 months
Results and safety
The study was stopped early (reason given: The low recruitment rate makes it very difficult to complete the study within a reasonable period of time.). Results are not available in the source record.
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.
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 principal investigator
Service of Pediatric Hematology-Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Expanded haploidentical natural killer cells (NKAEs) in people with Relapsed/Refractory Paediatric T Cell Lymphoblastic Leukaemia and Lymphoma, run by Hospital Infantil Universitario Niño Jesús, Madrid, Spain at 1 site 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 5 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: stopped early, 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 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: The low recruitment rate makes it very difficult to complete the study within a reasonable period of time.). Results are not available in the source record.
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?
Safety profile (number of AEs per patient) (time frame: Two months). 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 NCT01944982, 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.