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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03356080
• Other study ID #: DLAAG
• Status: Recruiting
• Phase: Phase 2
• First received: November 9, 2017
• Last updated: November 22, 2017
• Start date: July 7, 2017
• Est. completion date: July 7, 2020

Study information

• Verified date: November 2017
• Source: Shanghai Tong Ren Hospital
• Contact: Ligen Liu
• Phone: 18017337037
• Email: llg3532[@]shtrhospital.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. corresponding to the AML (except M3) or high-risk MDS diagnostic criteria, with any of the following circumstances:

?secondary AML patients (including AML secondary to MDS)

?corresponding 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.

?corresponding 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

?corresponding 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Decitabine
Decitabine,iv,0.1-0.2mg/kg, Day1-Day3 per week,up to 3 weeks
• Cytarabine
cytarabine, iv,15mg/m2 q12h, Day1-Day10
• All-transretinoic acid
All-transretinoic acid, 45mg/d Day4-Day6;15mg/d Day7-Day20
• G-CSF
G-CSF 300ug,sc,Day 0 until CR is achieved

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing
China	Fujian Medical University Union Hospital	Fuzhou
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning
China	Shanghai Tong Ren hospital	Shanghai
China	The center hospital of Shanghai Fengxian District	Shanghai
China	First Affiliated Hospital of Zhengzhou University.	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Tong Ren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Early death rate	The rate of early death within 30 days	the death rate after treating Day1 to Day30
Secondary	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	from enrolling to the end of 2-year following up
Secondary	Overall survival(OS)	The time from the date of enrolling to the date of death due to any reasons or the last following date	from enrolling to the end of 2-year following up
Secondary	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	from enrolling to the end of 2-year following up
Secondary	Duration of hospitalization	The time from the date of be hospitalized to the date of be discharged	from enrolling to the end of 2-year following up
Secondary	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	from enrolling to the end of 2-year following up