Acute Myeloid LeukemiaPhase 2HINKLNCT02229266
Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML
A Phase 2 study testing NK cells and Cytarabine in people with Acute Myeloid Leukemia, run by Technische Universität Dresden at 3 sites in Germany.
Trial summary
The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural killer cells compared to standard chemotherapy (after first complete remission) in patients with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for allogeneic transplantation Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- NK cells and Cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2015to 22 Apr 2017
- 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 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria
- In AML defined by cytogenetic aberrations the proportion of blasts may be <20%
- Age ≥60 years
- Clinical performance corresponding to ECOG score 0-2
- High-risk karyotype
- <5% myeloblasts in bone marrow ≥21 days after beginning of most recent chemotherapy
- maximal two preceding chemotherapy cycles
- Potentially available haploidentical family donor (child/ sibling), willing and fit for NK cell donation
Who cannot join
- AML with favorable or intermediate risk cytogenetic features
- Persistent aplasia following preceding chemotherapy
- Relapsed or refractory AML
- Known pre-existing autoimmune diseases
- Any severe concomitant condition which makes it undesirable for the patient to participate in the study
- Any condition which could jeorpadize compliance of the protocol
- Participation in another clinical trial during or within 4 weeks before study entry
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinikum Bayreuth
Bayreuth
Klinikum Chemnitz
Chemnitz
Universitätsklinikum Dresden
Dresden
About this study
Official title: Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With Haploidentical Natural Killer Cells in High-risk Acute Myeloid Leukemia
The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural killer cells compared to standard chemotherapy (after first complete remission) in patients with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for allogeneic transplantation
Read the detailed description
Randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia
- Conditions
- Acute Myeloid Leukemia
- Being tested
- NK cells, Cytarabine
- Keywords
- AML, high-risk AML, acute myeloid leukemia, NK cells, haploidentical natural killer cells, immunotherapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK cellsBiological
Also called CD3-negative/ CD56-positive NK cells from HLA-haploidentical family, donors
CytarabineDrug
Also called chemotherapy
1 cycle of consolidation chemotherapy with high-dose cytarabine
| Study group | Role | What they receive |
|---|---|---|
| NK cells | Experimental | Infusion of haploidentical NK cells after immunosuppression with cyclophosphamide and fludarabine, followed by immunostimulatory treatment with interleukin-2 Receives: Biological: NK cells |
| Control Intervention | Active comparator | 1 cycle of consolidation chemotherapy with high-dose cytarabine Receives: Drug: Cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year overall survival
measure time of survival of each patiente up to 2 years after study inclusion
Measured: 2 years after study inclusion
Secondary outcomes (7)
Time to relapse
evaluate time to relapse for 2 years after study inclusion for each patient; calculate cumulative incidence of relapse
Measured: 2 years after study inclusion
Relapse-free survival
Measured: 2 years after study inclusion
Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment
Measured: timepoint of application of NK cells
NK cell analysis
Measured: 2 years after study inclusion
Clinical performance (ECOG score)
Measured: 2 years after study inclusion
Incidence and severity of GVHD
Measured: 6 months after start of treatment
Incidence of (S)AEs
Measured: 5 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startSep 2015
- Primary completion22 Apr 2017
- Study completion22 Apr 2017
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Martin Bornhäuser, Prof. Dr. med., Principal investigator, Universitätsklinikum Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229266
- Sponsor's protocol ID
- TUD-HINKL1-059
- Acronym
- HINKL
- Status last verified
- Aug 2021
- First submitted
- 28 Aug 2014
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With Haploidentical Natural Killer Cells in High-risk Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02229266
- Acronym / sponsor ID
- HINKL / TUD-HINKL1-059
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, high-risk AML, acute myeloid leukemia, NK cells, haploidentical natural killer cells, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Sep 2015
- Primary completion
- 22 Apr 2017 (actual)
- Study completion
- 22 Apr 2017 (actual)
- First posted
- 1 Sep 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.
The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural killer cells compared to standard chemotherapy (after first complete remission) in patients with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for allogeneic transplantation
Detailed description
Randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NK cells | Experimental | Biological: NK cellsInfusion of haploidentical NK cells after immunosuppression with cyclophosphamide and fludarabine, followed by immunostimulatory treatment with interleukin-2 |
| Control Intervention | Active comparator | Drug: Cytarabine1 cycle of consolidation chemotherapy with high-dose cytarabine |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria
- In AML defined by cytogenetic aberrations the proportion of blasts may be <20%
- Age ≥60 years
- Clinical performance corresponding to ECOG score 0-2
- High-risk karyotype
Key exclusion criteria (7 listed)
- AML with favorable or intermediate risk cytogenetic features
- Persistent aplasia following preceding chemotherapy
- Relapsed or refractory AML
- Known pre-existing autoimmune diseases
- Any severe concomitant condition which makes it undesirable for the patient to participate in the study
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 |
|---|---|---|
| NK cellsAlso: CD3-negative/ CD56-positive NK cells from HLA-haploidentical family, donors | Biological | NK cells |
| CytarabineAlso: chemotherapy1 cycle of consolidation chemotherapy with high-dose cytarabine | Drug | Control Intervention |
Primary outcome
2-year overall survival
Time frame: 2 years after study inclusion
measure time of survival of each patiente up to 2 years after study inclusion
7 secondary outcomes
Time to relapse
Time frame: 2 years after study inclusion
Relapse-free survival
Time frame: 2 years after study inclusion
Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment
Time frame: timepoint of application of NK cells
NK cell analysis
Time frame: 2 years after study inclusion
Clinical performance (ECOG score)
Time frame: 2 years after study inclusion
Incidence and severity of GVHD
Time frame: 6 months after start of treatment
Incidence of (S)AEs
Time frame: 5 weeks after start of treatment
Results and safety
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Study Alliance LeukemiaLink provided by the sponsor.
- Universitätsklinikum Dresden, Medizinische Klinik ILink provided by the sponsor.
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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.
Martin Bornhäuser, Prof. Dr. med. principal investigator
Universitätsklinikum Dresden
3 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 NK cells and Cytarabine in people with Acute Myeloid Leukemia, run by Technische Universität Dresden at 3 sites in Germany.
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 8 inclusion and 7 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 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 was stopped early (reason given: low recruitment rate). 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?
2-year overall survival (time frame: 2 years after study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2021.