Overview

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

Status:
Unknown status

Trial end date:
2020-07-07

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Shanghai Tong Ren Hospital

Treatments:

Azacitidine
Cytarabine
Decitabine
Lenograstim
Tretinoin

Criteria

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