AMLPhase 2NCT02662647
Decitabine Based Chemotherapy Followed by Haploidentical Lymphocyte Infusion for Elderly Patients With AML
A Phase 2 study testing Decitabine 20 mg/m²/day for 5 days in people with AML, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory molecules and adhesion molecules. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- AML
- What is being tested?
- Decitabine 20 mg/m²/day for 5 days
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Mar 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a diagnosis of AML based on 2008 World Health Organization (WHO) classification of myeloid malignancies
- Must have life expectancy >= 3 months
- Must have the ability to observe the efficacy and events
- Must have no accompany therapy(including steroid)
- 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
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- Must have haploidentical donor
- DONOR Inclusion Criteria:
- Must have signed the standard informed consent form; if sufficient cryopreserved cells remain from a previous donation, no additional donation or consent is required
- Both men and women and members of all races and ethnic groups are eligible for this trial
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
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- 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
- DONOR Exclusion Criteria:
- Must not have any underlying conditions which would contra-indicate apheresis
- Must not be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory molecules and adhesion molecules. The leukemias cells treated by decitabine will become more sensitive to the following adoptive T cell therapy.We proposed a hypothesis that decitabine-based chemotherapy acts in synergestic with haploidentical lymphocyte infusion in eliciting leukemia specific cytotoxic lymphocyte(CTL) and diminishing leukemic cells.
- Conditions
- AML
- Being tested
- Decitabine 20 mg/m²/day for 5 days
- Keywords
- demethylating agent, lymphocyte infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine 20 mg/m²/day for 5 daysDrug
Also called Cytarabine, aclacinomycin
| Study group | Role | What they receive |
|---|---|---|
| DCAG plus HLI | Experimental | Patient will be treated with decitabine and modified CAG regimen followed by HLA haploidentical peripheral mononuclear blood cells infusion. Receives: Drug: Decitabine 20 mg/m²/day for 5 days |
| DCAG | Experimental | Patient will be treated with decitabine combining modified CAG regimen without other treatments. Receives: Drug: Decitabine 20 mg/m²/day for 5 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission(CR) rate
Measured: 3 months
Secondary outcomes (1)
overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2018
- Study completionMar 2019
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 AMLStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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-Xin Wang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662647
- Sponsor's protocol ID
- ChinaNGH-H001
- Status last verified
- Jun 2019
- First submitted
- 20 Jan 2016
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Wang LX, Mei ZY, Zhou JH, Yao YS, Li YH, Xu YH, Li JX, Gao XN, Zhou MH, Jiang MM, Gao L, Ding Y, Lu XC, Shi JL, Luo XF, Wang J, Wang LL, Qu C, Bai XF, Yu L. Low dose decitabine treatment induces CD80 expression in cancer cells and stimulates tumor specific cytotoxic T lymphocyte responses. PLoS One. 2013 May 9;8(5):e62924. doi: 10.1371/journal.pone.0062924. Print 2013.
PubMed 23671644
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decitabine Based Chemotherapy Followed by Haploidentical Lymphocyte Infusion for Elderly Patients With AML
- ClinicalTrials.gov ID
- NCT02662647
- Acronym / sponsor ID
- ChinaNGH-H001
- Conditions
- AML
- Keywords
- demethylating agent, lymphocyte infusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Navy General Hospital, Beijing
- Study start
- Apr 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 25 Jan 2016 (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.
Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory molecules and adhesion molecules. The leukemias cells treated by decitabine will become more sensitive to the following adoptive T cell therapy.We proposed a hypothesis that decitabine-based chemotherapy acts in synergestic with haploidentical lymphocyte infusion in eliciting leukemia specific cytotoxic lymphocyte(CTL) and diminishing leukemic cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCAG plus HLI | Experimental | Drug: Decitabine 20 mg/m²/day for 5 daysPatient will be treated with decitabine and modified CAG regimen followed by HLA haploidentical peripheral mononuclear blood cells infusion. |
| DCAG | Experimental | Drug: Decitabine 20 mg/m²/day for 5 daysPatient will be treated with decitabine combining modified CAG regimen without other treatments. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must have a diagnosis of AML based on 2008 World Health Organization (WHO) classification of myeloid malignancies
- Must have life expectancy >= 3 months
- Must have the ability to observe the efficacy and events
- Must have no accompany therapy(including steroid)
- 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
Key exclusion criteria (11 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 |
|---|---|---|
| Decitabine 20 mg/m²/day for 5 daysAlso: Cytarabine, aclacinomycin | Drug | DCAG, DCAG plus HLI |
Primary outcome
complete remission(CR) rate
Time frame: 3 months
1 secondary outcome
overall survival
Time frame: 2 years
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 10 Jun 2019.
- Background: PubMed 23671644Wang LX, Mei ZY, Zhou JH, Yao YS, Li YH, Xu YH, Li JX, Gao XN, Zhou MH, Jiang MM, Gao L, Ding Y, Lu XC, Shi JL, Luo XF, Wang J, Wang LL, Qu C, Bai XF, Yu L. Low dose decitabine treatment induces CD80 expression in cancer cells and stimulates tumor specific cytotoxic T lymphocyte responses. PLoS One. 2013 May 9;8(5):e62924. doi: 10.1371/journal.pone.0062924. Print 2013.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decitabine 20 mg/m²/day for 5 days in people with AML, 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 10 inclusion and 11 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 10 Jun 2019. 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 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?
complete remission(CR) rate (time frame: 3 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 NCT02662647, 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 10 Jun 2019.