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

NCT03356080 | Unknown Phase 2

• 1 other identifier: DLAAG
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (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).

  at the end of every course(about 4 weeks)

Secondary Outcomes (6)

• Early death rate

  the death rate after treating Day1 to Day30

• Leukemia free survival (LFS)

  from enrolling to the end of 2-year following up

• Overall survival(OS)

  from enrolling to the end of 2-year following up

• The rate of adverse reaction the rate of adverse reaction

  from enrolling to the end of 2-year following up

• Duration of hospitalization

  from enrolling to the end of 2-year following up

Study Arms (1)

DLAAG

EXPERIMENTAL

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; Drug: Cytarabine; Drug: All-transretinoic acid; Drug: G-CSF

Interventions

Decitabine DRUG

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

Also known as: Qingweike

DLAAG

Cytarabine DRUG

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

Also known as: Cytosar

DLAAG

All-transretinoic acid DRUG

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

Also known as: Ailike

DLAAG

G-CSF DRUG

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

Also known as: Filgrastim

DLAAG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Tong Ren Hospital: lead

Study Sites (6)

Beijing Friendship Hospital

Beijing, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, China

NOT YET RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

NOT YET RECRUITING

Shanghai Tong Ren hospital

Shanghai, China

RECRUITING

The center hospital of Shanghai Fengxian District

Shanghai, China

NOT YET RECRUITING

First Affiliated Hospital of Zhengzhou University.

Zhengzhou, China

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Decitabine; Cytarabine; Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Arabinonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ligen Liu

  Shanghai Tong Ren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ligen Liu

CONTACT

18017337037; llg3532@shtrhospital.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of hematology department

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 29, 2017
• Study Start: July 7, 2017
• Primary Completion: July 7, 2019
• Study Completion: July 7, 2020
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

CN (6)