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

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Decitabine

Cytarabine

All-transretinoic acid

G-CSF

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring decitabine, retinoid acid, cytarabine C, Granulocyte Colony Stimulating Factor, acute myeloid leukemia, Myelodysplastic Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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

Sites / Locations

Beijing Friendship Hospital
Fujian Medical University Union Hospital
The People's Hospital of Guangxi Zhuang Autonomous Region
Shanghai Tong Ren hospitalRecruiting
The center hospital of Shanghai Fengxian District
First Affiliated Hospital of Zhengzhou University.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DLAAG

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Early death rate

The rate of early death within 30 days

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

Overall survival(OS)

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

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

Duration of hospitalization

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

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

Full Information

NCT ID

NCT03356080

First Posted

November 9, 2017

Last Updated

November 22, 2017

Sponsor

Shanghai Tong Ren Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03356080

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 7, 2017 (Actual)

Primary Completion Date

July 7, 2019 (Anticipated)

Study Completion Date

July 7, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Tong Ren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia, Myelodysplastic Syndrome

Keywords

decitabine, retinoid acid, cytarabine C, Granulocyte Colony Stimulating Factor, acute myeloid leukemia, Myelodysplastic Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DLAAG

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Decitabine

Other Intervention Name(s)

Qingweike

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cytarabine

Other Intervention Name(s)

Cytosar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

All-transretinoic acid

Other Intervention Name(s)

Ailike

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

G-CSF

Other Intervention Name(s)

Filgrastim

Intervention Description

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

Primary Outcome Measure Information:

Title

Complete Response Rate (CR)

Description

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).

Time Frame

at the end of every course(about 4 weeks)

Secondary Outcome Measure Information:

Title

Early death rate

Description

The rate of early death within 30 days

Time Frame

the death rate after treating Day1 to Day30

Title

Leukemia free survival (LFS)

Description

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

Time Frame