Recurrent Adult Acute Myeloid LeukemiaPhase 1/2NCT01758367
Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation
A Phase 1/2 study testing Deciatbine(DAC) in people with Recurrent Adult Acute Myeloid Leukemia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Decitabine can up-regulate a series of immune associated proteins, including cancer testis antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and adhesion molecules, which suggests a potential benefit for a following adoptive T cell therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Recurrent Adult Acute Myeloid Leukemia
- What is being tested?
- Deciatbine(DAC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Jun 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 60 years
- Histologically or cytologically documented relapse of acute myeloid leukemia after a stem cell transplant
- Must have the ability to observe the efficacy and events
- Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 3
- Must have suitable donor
Who cannot join
- Must not have an advanced malignant hepatic tumor
- Must not receive any other forms of chemotherapy after cell infusion during the treatment protocol
- Must not be receiving any other investigational agents within 14 days of first dose of study drug
- Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this study
- Must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or other agents used in the study
- Must not have a known or suspected hypersensitivity to decitabine
- Must not be human immunodeficiency virus (HIV)-positive and on combination antiretroviral therapy; these patients are ineligible because of the potential for pharmacokinetic interactions with decitabine; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Li Yu, MD, PhD, 86-010-55499003, chunhuiliyu@yahoo.com
Li-Xin Wang, MD, PhD, 86-010-66958509, wanglixin1991@sohu.com
About this study
Decitabine can up-regulate a series of immune associated proteins, including cancer testis antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and adhesion molecules, which suggests a potential benefit for a following adoptive T cell therapy. In addition, decitabine induce FOXP3 expression in CD4+ T cells and convert CD4+ T cells into T regulatory cells(Tregs). As a result, Graft versus host disease(GVHD) can be reduced by treatment of decitabine.
- Conditions
- Recurrent Adult Acute Myeloid Leukemia
- Being tested
- Deciatbine(DAC)
- Keywords
- demethylating agent, immunogenicity, decitabine(DAC), donor lymphocyte infusion(DLI), AML
- 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.
Deciatbine(DAC)Drug
Also called 5-aza-2'-deoxycytidine
| Study group | Role | What they receive |
|---|---|---|
| Decitabine+DLI | Experimental | Patients with relapsed AML after Allo-HSCT will be treated with decitabine and DLI. Receives: Drug: Deciatbine(DAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
Measured: 4 months
Secondary outcomes (1)
overall survival
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Adult Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Navy General Hospital, Beijing
- Responsible party
- Principal investigator, Li Yu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758367
- Sponsor's protocol ID
- CN301-XYK-002
- Status last verified
- Aug 2016
- First submitted
- 27 Dec 2012
- Last updated
- 31 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01758367
- Acronym / sponsor ID
- CN301-XYK-002
- Conditions
- Recurrent Adult Acute Myeloid Leukemia
- Keywords
- demethylating agent, immunogenicity, decitabine(DAC), donor lymphocyte infusion(DLI), AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Navy General Hospital, Beijing
- Study start
- Dec 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 1 Jan 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.
Decitabine can up-regulate a series of immune associated proteins, including cancer testis antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and adhesion molecules, which suggests a potential benefit for a following adoptive T cell therapy. In addition, decitabine induce FOXP3 expression in CD4+ T cells and convert CD4+ T cells into T regulatory cells(Tregs). As a result, Graft versus host disease(GVHD) can be reduced by treatment of decitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine+DLI | Experimental | Drug: Deciatbine(DAC)Patients with relapsed AML after Allo-HSCT will be treated with decitabine and DLI. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 - 60 years
- Histologically or cytologically documented relapse of acute myeloid leukemia after a stem cell transplant
- Must have the ability to observe the efficacy and events
- Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 3
Key exclusion criteria (8 listed)
- Must not have an advanced malignant hepatic tumor
- Must not receive any other forms of chemotherapy after cell infusion during the treatment protocol
- Must not be receiving any other investigational agents within 14 days of first dose of study drug
- Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this 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 |
|---|---|---|
| Deciatbine(DAC)Also: 5-aza-2'-deoxycytidine | Drug | Decitabine+DLI |
Primary outcome
complete remission rate
Time frame: 4 months
1 secondary outcome
overall survival
Time frame: 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
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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.
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 Deciatbine(DAC) in people with Recurrent Adult Acute Myeloid Leukemia, run by Chinese PLA General Hospital 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 6 inclusion and 8 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 31 Aug 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?
Contact Li Yu, MD, PhD (86-010-55499003, chunhuiliyu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate (time frame: 4 months). 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 31 Aug 2016.