Clinical trial · Interventional
DLAAG in the Treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome With Blast Excess
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
NCT03356080CI-TRIAL-00030590unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| All-transretinoic acid | Drug | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Decitabine | Drug | Decitabine | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DLAAG
- 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
- interventionNames
- Drug: Decitabine
- Drug: Cytarabine
- Drug: All-transretinoic acid
- Drug: G-CSF
Primary outcomes (1)
- measure
- Complete Response Rate (CR)
- timeFrame
- at the end of every course(about 4 weeks)
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.