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Acute Myeloid LeukemiaPhase 2NCT03356080

DLAAG in the Treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess

A Phase 2 study testing Decitabine, Cytarabine and All-transretinoic acid in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Shanghai Tong Ren Hospital at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate of the clinical efficacy and safety of DLAAG protocol in the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome with blast excess Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Decitabine, Cytarabine and All-transretinoic acid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
6 sitesChina
Study dates
7 Jul 2017to 7 Jul 2020
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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • corresponding to the AML (except M3) or high-risk MDS diagnostic criteria, with any of the following circumstances:
  • ①secondary AML patients (including AML secondary to MDS)
  • ②corresponding to refractory AML diagnostic standard ( relapsed refractory acute myeloid leukemia Chinese guidelines(2017 Edition): Refractory AML diagnostic criteria: invalid after standard treatment 2 cycles of untreated cases; consolidation therapy after CR and then recurrence within 12 months; recurrence after 12 months and then invalid after conventional chemotherapy ; relapse of ≥ 2 times ; extramedullary leukemia continued existence.
  • ③corresponding to recurrent AML diagnostic criteria (relapsed refractory acute myeloid leukemia China guidelines (2017 Edition): peripheral blood leukemia cells or bone marrow progenitor cells appear again > 0.050 after CR (with the exception of bone marrow regeneration after consolidation chemotherapy and other reasons) or leukemia cells infiltration appear in extramedullary
  • ④corresponding to MDS refractory anemia with blasts excess (RAEB) diagnosis standards
  • Age ≥18 years old
Show all 9Show fewer
  • Eastern Cooperative Oncology Group(ECOG) score 0-3
  • Expected survival ≥8 weeks
  • Patients must be able to understand and be willing to participate in this study, and signed informed consent

Who cannot join

  • acute promyelocytic leukemia (M3 type)
  • Other types of MDS patients except RAEB
  • with other advanced malignant tumors
  • patients with uncontrolled severe infection, and can not tolerate chemotherapy with other serious underlying diseases
  • patients with heart failure: ejection fraction (EF) < 30%, New York Heart Association(NYHA) standard, cardiac insufficiency in class II or above

Trial locations and contacts

6 sites in 1 country.

Ligen Liu contact

18017337037

llg3532@shtrhospital.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Beijing Friendship Hospital

    Beijing

    Not yet recruiting

  • Fujian Medical University Union Hospital

    Fuzhou

    Not yet recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning

    Not yet recruiting

  • Shanghai Tong Ren hospital

    Shanghai

    Ligen Liu, 18017337037, llg3532@shtrhospital.com

    Recruiting

  • The center hospital of Shanghai Fengxian District

    Shanghai

    Not yet recruiting

  • First Affiliated Hospital of Zhengzhou University.

    Zhengzhou

    Not yet recruiting

Other trials in China

About this study

Official title: Clinical Efficacy and Safety of DLAAG Protocol in the Treatment of Refractory/Relapse of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess: a Multicenter, Single-arm, Prospective Clinical Study

The purpose of this study is to evaluate of the clinical efficacy and safety of DLAAG protocol in the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome with blast excess

Being tested
Decitabine, Cytarabine, All-transretinoic acid, G-CSF
Keywords
decitabine, retinoid acid, cytarabine C, Granulocyte Colony Stimulating Factor, acute myeloid leukemia, Myelodysplastic Syndrome
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

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

  • DecitabineDrug

    Also called Qingweike

    Decitabine,iv,0.1-0.2mg/kg, Day1-Day3 per week,up to 3 weeks

  • CytarabineDrug

    Also called Cytosar

    cytarabine, iv,15mg/m2 q12h, Day1-Day10

  • All-transretinoic acidDrug

    Also called Ailike

    All-transretinoic acid, 45mg/d Day4-Day6;15mg/d Day7-Day20

  • G-CSFDrug

    Also called Filgrastim

    G-CSF 300ug,sc,Day 0 until CR is achieved

Study groups in NCT03356080
Study groupRoleWhat they receive
DLAAGExperimentalAll patients receive 1-2 cycles of induction chemotherapy,that is DLAAG,which is expected to be 6 weeks/cycle,including decitabine,cytarabine, all-transretinoic acid,and Granulocyte Colony-Stimulating Factor(G-CSF). patients with CR after the first course of induction therapy (DLAAG) will continue to receive 1 cycle of consolidation therapy, while those with therapy failure will continue the second course of induction therapy. If CR is not achieved, quit the study. Patients who achieve CR after induction therapy will be in accordance with the guidelines, such as the proposed active treatment of allogeneic hematopoietic stem cell transplantation
Receives: Drug: Decitabine; Drug: Cytarabine; Drug: All-transretinoic acid; Drug: G-CSF

What is being measured

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

  1. Complete Response Rate (CR)

    Morphologic CR - patient independent of transfusions

    • Absolute neutrophil count(ANC) >1000/ Microliter(mcL)
    • Platelets ≥100,000/mcL
    • No residual evidence of extramedullary disease

    Cytogenetic CR - cytogenetics normal (in those with previously abnormal cytogenetics)

    Molecular CR - molecular studies negative

    CR with incomplete blood cells count recovery(CRi) - There are some clinical trials, particularly those that focus on the elderly or those with antecedent myelodysplasia, that include a variant of complete response referred to as CRi. This has been defined as <5% marrow blasts, either ANC <1000/mcL or platelets <100,000/mcL, and transfusion independence but with persistence of cytopenia (usually thrombocytopenia).

    Measured: at the end of every course(about 4 weeks)

Secondary outcomes (6)

  1. Early death rate

    The rate of early death within 30 days

    Measured: the death rate after treating Day1 to Day30

  2. Leukemia free survival (LFS)

    Morphologic leukemia-free state Bone marrow <5% blasts in an aspirate with spicules No blasts with Auer rods or persistence of extramedullary disease

    Measured: from enrolling to the end of 2-year following up

  3. Overall survival(OS)

    The time from the date of enrolling to the date of death due to any reasons or the last following date

    Measured: from enrolling to the end of 2-year following up

  4. The rate of adverse reaction the rate of adverse reaction

    the rate of adverse reaction, according to Standard for World Health Organization(WHO) acute and subacute toxicity

    Measured: from enrolling to the end of 2-year following up

  5. Duration of hospitalization

    The time from the date of be hospitalized to the date of be discharged

    Measured: from enrolling to the end of 2-year following up

  6. The rate of relapse

    Relapse following complete response is defined as reappearance of leukemic blasts in the peripheral blood or the finding of more than 5% blasts in the bone marrow, not attributable to another cause (eg, bone marrow regeneration after consolidation therapy) or extramedullary relapse

    Measured: from enrolling to the end of 2-year following up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2017
  2. Study start7 Jul 2017
  3. Primary completion7 Jul 2019 (estimated)
  4. Study completion7 Jul 2020 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03356080
Sponsor's protocol ID
DLAAG
Status last verified
Nov 2017
First submitted
9 Nov 2017
Last updated
29 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Decitabine, Cytarabine and All-transretinoic acid in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Shanghai Tong Ren Hospital at 6 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?

The sponsor lists 9 inclusion and 5 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 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ligen Liu (18017337037, llg3532@shtrhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate (CR) (time frame: at the end of every course(about 4 weeks)). 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 NCT03356080.

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 29 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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