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MDSPhase 1/2NCT01690507

Decitabine Combining Modified CAG Followed by HLA Haploidentical Peripheral Blood Mononuclear Cells Infusion for Elderly Patients With Acute Myeloid Leukemia(AML）

A Phase 1/2 study testing Decitabine, Cytarabine and aclacinomycin in people with MDS and AML, run by Chinese PLA General Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 55 to 75 years
Conditions the study is for
MDS, AML
What is being tested?
Decitabine, Cytarabine and aclacinomycin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesChina
Study dates
Nov 2012to Jan 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 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

PATIENT Inclusion Criteria:

  • Must have a diagnosis of MDS-RAEB or 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
  • 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

PATIENT Exclusion Criteria:

  • 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

DONOR Exclusion Criteria:

  • Must not have any underlying conditions which would contra-indicate apheresis
  • Must not be pregnant

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Navy General Hospital

    Beijing, Beijing Municipality, 100048

  • Chinese PLA General Hospital

    Beijing, 100853

Other trials in China

About this study

Official title: Phase 1/2 Study of Decitabine Combined With Modified CAG Followed by HLA Haploidentical T Cell Infusion in Treating Elderly Patients With Intermediate-high Risk Myelodysplastic Syndrome(MDS) or Acute Myeloid Leukemia(AML）

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.

Conditions
MDS, AML
Being tested
Decitabine, Cytarabine, aclacinomycin, Granulocyte colony-stimulating factor, HLA haploidentical mononuclear cells infusion
Keywords
demethylating agent, immunogenicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DecitabineDrug

    20 mg/m²/day for 5 days

  • CytarabineDrug

  • aclacinomycinDrug

  • Granulocyte colony-stimulating factorDrug

    Also called G-CSF

  • HLA haploidentical mononuclear cells infusionOther

    Also called DLI

Study groups in NCT01690507
Study groupRoleWhat they receive
DCAG plus HLIOtherNot described
Receives: Drug: Decitabine; Drug: Cytarabine; Drug: aclacinomycin; Drug: Granulocyte colony-stimulating factor; Other: HLA haploidentical mononuclear cells infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CR rate

    Measured: 3 months

Secondary outcomes (1)

  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.

  1. First posted21 Sep 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionMay 2015
  4. Study completionJan 2016

Resources

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01690507
Sponsor's protocol ID
CN301-XYK-001
Status last verified
Feb 2016
First submitted
19 Sep 2012
Last updated
25 Feb 2016
Results posted
No
Data monitoring committee
No

Publications

  • Jing Y, Jin X, Wang L, Dou L, Wang Q, Yao Y, Lian S, Zhou J, Zhu H, Yao Z, Gao L, Wang L, Li Y, Bai X, Fang M, Yu L. Decitabine-based chemotherapy followed by haploidentical lymphocyte infusion improves the effectiveness in elderly patients with acute myeloid leukemia. Oncotarget. 2016 Aug 10;8(32):53654-53663. doi: 10.18632/oncotarget.11183. eCollection 2017 Aug 8.

    PubMed 28881839

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Decitabine, Cytarabine and aclacinomycin in people with MDS and AML, run by Chinese PLA General Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 25 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 2 sites 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?

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?

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 NCT01690507, 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 25 Feb 2016.

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