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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Myelodysplastic Syndrome; Acute Myeloid Leukemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03356080

DLAAG

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

DLAAG

Experimental group

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

Treatment:

Drug: Cytarabine

Drug: Decitabine

Drug: G-CSF

Drug: All-transretinoic acid