Acute LeukemiaPhase 1/2NCT01956630
Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT
A Phase 1/2 study testing Genetically modified DCs plus CIK cells and Donor leukocyte infusions (DLI) in people with Acute Leukemia, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient survival, is so far treated by second transplantation and donor leukocyte infusion (DLI), which seems to have high risk and low… Read more about this study
- Who is it for?
- Ages 8 to 61 years
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Genetically modified DCs plus CIK cells and Donor leukocyte infusions (DLI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 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 8 to 61 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- AL patients according to the WHO criteria
- expected survival duration of more than 3 months
- age between 8 and 61years
Who cannot join
- underlying autoimmune disease
- positive serology for HIV infection
- chronic active hepatitis
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hematopoietic Stem Cell Transplantation
Beijing, 100071
About this study
Official title: Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT
Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient survival, is so far treated by second transplantation and donor leukocyte infusion (DLI), which seems to have high risk and low survival. Need for a new medication on relapse is urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual disease. This randomized study was conducted to evaluate the feasibility and effective of genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.
- Conditions
- Acute Leukemia
- Being tested
- Genetically modified DCs plus CIK cells, Donor leukocyte infusions (DLI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetically modified DCs plus CIK cellsBiological
Donor leukocyte infusions (DLI)Biological
| Study group | Role | What they receive |
|---|---|---|
| Genetically modified DCs plus CIK cells | Experimental | Patients received four subcutaneous injections of 2-5×10e7 cells of DCs at the groin, axilla, and neck respectively on days 7, 9, 11, and 13 and i.v. infusions of 2-15×10e9 CIK on days 11 and 13 per cycle. The cycle was repeated until Wilms' tumor 1(WT1) turned negative by polymerase chain reaction(PCR) or graft-versus-host disease(GVHD) appeared. Receives: Biological: Genetically modified DCs plus CIK cells |
| Donor leukocyte infusions (DLI) | Active comparator | Patients received DLI at a dose of 2×10e7/kg, 5×10e7/kg and 1×10e8/kg cluster of differentiation 3(CD3)+ cells at months 1, 2 and 3 respectively unless GVHD appeared. Receives: Biological: Donor leukocyte infusions (DLI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: up to 3 years
Secondary outcomes (1)
Gvhd incidence
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Acute LeukemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hu Chen, Doctor, Principal investigator, Affiliated Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956630
- Sponsor's protocol ID
- 307-CTC-DC/CIK-Leukemia
- Status last verified
- Feb 2016
- First submitted
- 23 Sep 2013
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang D, Huang XF, Hong B, Song XT, Hu L, Jiang M, Zhang B, Ning H, Li Y, Xu C, Lou X, Li B, Yu Z, Hu J, Chen J, Yang F, Gao H, Ding G, Liao L, Rollins L, Jones L, Chen SY, Chen H. Efficacy of intracellular immune checkpoint-silenced DC vaccine. JCI Insight. 2018 Feb 8;3(3):e98368. doi: 10.1172/jci.insight.98368. eCollection 2018 Feb 8.
PubMed 29415891
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT
- ClinicalTrials.gov ID
- NCT01956630
- Acronym / sponsor ID
- 307-CTC-DC/CIK-Leukemia
- Conditions
- Acute Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Oct 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.
Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient survival, is so far treated by second transplantation and donor leukocyte infusion (DLI), which seems to have high risk and low survival. Need for a new medication on relapse is urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual disease. This randomized study was conducted to evaluate the feasibility and effective of genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetically modified DCs plus CIK cells | Experimental | Biological: Genetically modified DCs plus CIK cellsPatients received four subcutaneous injections of 2-5×10e7 cells of DCs at the groin, axilla, and neck respectively on days 7, 9, 11, and 13 and i.v. infusions of 2-15×10e9 CIK on days 11 and 13 per cycle. The cycle was repeated until Wilms' tumor 1(WT1) turned negative by polymerase chain reaction(PCR) or graft-versus-host disease(GVHD) appeared. |
| Donor leukocyte infusions (DLI) | Active comparator | Biological: Donor leukocyte infusions (DLI)Patients received DLI at a dose of 2×10e7/kg, 5×10e7/kg and 1×10e8/kg cluster of differentiation 3(CD3)+ cells at months 1, 2 and 3 respectively unless GVHD appeared. |
Who may qualify
- Ages
- 8 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- AL patients according to the WHO criteria
- expected survival duration of more than 3 months
- age between 8 and 61years
Key exclusion criteria (3 listed)
- underlying autoimmune disease
- positive serology for HIV infection
- chronic active hepatitis
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 |
|---|---|---|
| Genetically modified DCs plus CIK cells | Biological | Genetically modified DCs plus CIK cells |
| Donor leukocyte infusions (DLI) | Biological | Donor leukocyte infusions (DLI) |
Primary outcome
Overall survival
Time frame: up to 3 years
1 secondary outcome
Gvhd incidence
Time frame: 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
- Derived from this study: PubMed 29415891Wang D, Huang XF, Hong B, Song XT, Hu L, Jiang M, Zhang B, Ning H, Li Y, Xu C, Lou X, Li B, Yu Z, Hu J, Chen J, Yang F, Gao H, Ding G, Liao L, Rollins L, Jones L, Chen SY, Chen H. Efficacy of intracellular immune checkpoint-silenced DC vaccine. JCI Insight. 2018 Feb 8;3(3):e98368. doi: 10.1172/jci.insight.98368. eCollection 2018 Feb 8.
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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.
Hu Chen, Doctor principal investigator
Affiliated Hospital to Academy of Military Medical Sciences
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 Genetically modified DCs plus CIK cells and Donor leukocyte infusions (DLI) in people with Acute Leukemia, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Feb 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 China. 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?
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?
Overall survival (time frame: up to 3 years). 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 NCT01956630, 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 22 Feb 2016.