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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03356080
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Information provided by (Responsible Party):
Liu Ligen, Shanghai Tong Ren Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Drug: Decitabine Drug: Cytarabine Drug: All-transretinoic acid Drug: G-CSF Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : July 7, 2019
Estimated Study Completion Date : July 7, 2020

Arm Intervention/treatment
Experimental: DLAAG

All 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

Drug: Decitabine
Decitabine,iv,0.1-0.2mg/kg, Day1-Day3 per week,up to 3 weeks
Other Name: Qingweike

Drug: Cytarabine
cytarabine, iv,15mg/m2 q12h, Day1-Day10
Other Name: Cytosar

Drug: All-transretinoic acid
All-transretinoic acid, 45mg/d Day4-Day6;15mg/d Day7-Day20
Other Name: Ailike

Drug: G-CSF
G-CSF 300ug,sc,Day 0 until CR is achieved
Other Name: Filgrastim

Primary Outcome Measures :
  1. Complete Response Rate (CR) [ Time Frame: at the end of every course(about 4 weeks) ]

    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).

Secondary Outcome Measures :
  1. Early death rate [ Time Frame: the death rate after treating Day1 to Day30 ]
    The rate of early death within 30 days

  2. Leukemia free survival (LFS) [ Time Frame: from enrolling to the end of 2-year following up ]
    Morphologic leukemia-free state Bone marrow <5% blasts in an aspirate with spicules No blasts with Auer rods or persistence of extramedullary disease

  3. Overall survival(OS) [ Time Frame: from enrolling to the end of 2-year following up ]
    The time from the date of enrolling to the date of death due to any reasons or the last following date

  4. The rate of adverse reaction the rate of adverse reaction [ Time Frame: from enrolling to the end of 2-year following up ]
    the rate of adverse reaction, according to Standard for World Health Organization(WHO) acute and subacute toxicity

  5. Duration of hospitalization [ Time Frame: from enrolling to the end of 2-year following up ]
    The time from the date of be hospitalized to the date of be discharged

  6. The rate of relapse [ Time Frame: from enrolling to the end of 2-year following up ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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

  2. Age ≥18 years old
  3. Eastern Cooperative Oncology Group(ECOG) score 0-3
  4. Expected survival ≥8 weeks
  5. Patients must be able to understand and be willing to participate in this study, and signed informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03356080

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Contact: Ligen Liu 18017337037

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Beijing Friendship Hospital Not yet recruiting
Beijing, China
Fujian Medical University Union Hospital Not yet recruiting
Fuzhou, China
The People's Hospital of Guangxi Zhuang Autonomous Region Not yet recruiting
Nanning, China
Shanghai Tong Ren hospital Recruiting
Shanghai, China
Contact: Ligen Liu    18017337037   
The center hospital of Shanghai Fengxian District Not yet recruiting
Shanghai, China
First Affiliated Hospital of Zhengzhou University. Not yet recruiting
Zhengzhou, China
Sponsors and Collaborators
Shanghai Tong Ren Hospital
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Principal Investigator: Ligen Liu Shanghai Tong Ren Hospital

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Responsible Party: Liu Ligen, head of hematology department, Shanghai Tong Ren Hospital Identifier: NCT03356080     History of Changes
Other Study ID Numbers: DLAAG
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liu Ligen, Shanghai Tong Ren Hospital:
retinoid acid
cytarabine C
Granulocyte Colony Stimulating Factor
acute myeloid leukemia
Myelodysplastic Syndrome
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Enzyme Inhibitors
Keratolytic Agents
Dermatologic Agents