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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-07

Study Completion Date

2020-07-07

Brief Summary

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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

Detailed Description

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Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndrome

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

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

Cytarabine

Intervention Type DRUG

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

All-transretinoic acid

Intervention Type DRUG

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

G-CSF

Intervention Type DRUG

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

Interventions

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Decitabine

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

Intervention Type DRUG

Cytarabine

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

Intervention Type DRUG

All-transretinoic acid

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

Intervention Type DRUG

G-CSF

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

Intervention Type DRUG

Other Intervention Names

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Qingweike Cytosar Ailike Filgrastim

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Liu Ligen

head of hematology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ligen Liu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Tong Ren Hospital

Locations

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