Combination of Venetoclax, Hypomethylation Agent and Low-dose Cytarabine as a Salvage Therapy for Acute Myeloid Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Although studies are ongoing to evaluate the efficiency and safety of venetoclax-based therapy, alone or in combination with hypomethylation agent or low-dose cytarabine, in relapsed/refractory acute myeloid leukemia, data are scarce and heterogenous. In this study, the investigators aimed to assess safety and response to a new venetoclax-based triple-drug combination regimen (venetoclax + hypomethylation agent + low-dose cytarabine) in acute myeloid leukemia patients who had relapsed/refractory disease or positive minimal residual disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Venetoclax Based Regimen in Prevention Relapse of Consecutive MRD Positive AML Patients

NCT05361057

Acute Myeloid Leukemia Measurable Disease

TERMINATED PHASE2

Prolonged Ultra Low-dose Decitabine Plus Venetoclax for Primary Diagnosed Elderly AMLK/MDS

NCT06046313

Acute Myeloid Leukemia Myelodysplastic Syndromes

RECRUITING PHASE2

Intensive Therapy Combined With Venetoclax for Adult Acute Myeloid Leukemia

NCT05356169

Acute Myeloid Leukemia

ACTIVE_NOT_RECRUITING PHASE2/PHASE3

A Phase 2 Study of Venetoclax in Combination With Low-dose HHT, G-CSF, and AZA as First-line Treatment for Newly Diagnosed Elderly AML Patients Unfit for Intensive Chemotherapy

NCT04824924

Leukemia, Myeloid, Acute

UNKNOWN PHASE2

Reduced Intensive Idarubicin and Cytarabine Plus Venetoclax as First-line Treatment for Adults AML and MDS

NCT06050941

Acute Myeloid Leukemia Myelodysplastic Syndromes

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Although the promising activity of venetoclax-based therapy is well demonstrated in the treatment of previously untreated elderly or unfit patients with acute myeloid leukemia, there are few data on the efficacy of venetoclax-based salvage therapy in relapsed/refractory patients, which can be difficult to treat. To date, data on venetoclax as monotherapy or in combination with hypomethylation agent or low-dose cytarabine as a salvage regimen in relapsed/refractory AML are scarce and heterogenous. In this study, the investigators aimed to assess safety and efficiency of a new triple-drug combination regimen, venetoclax + hypomethylation agent + low-dose cytarabine, in patients with relapsed/refractory acute myeloid leukemia or persistent positive minimal residual disease in the salvage setting.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsed Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Minimal Residual Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

venetoclax + Hypomethylation agent + low-dose cytarabine treatment group

patients treated with venetoclax combined with decitabine/azacytidine and low-dose cytarabine

Group Type EXPERIMENTAL

Venetoclax, Decitabine, Azacytidine, Cytarabine

Intervention Type DRUG

Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days (n=3) or azacytidine (n=8) was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. Cytarabine was given at a dose of 10 mg/m2 twice daily for 7 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Venetoclax, Decitabine, Azacytidine, Cytarabine

Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days (n=3) or azacytidine (n=8) was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. Cytarabine was given at a dose of 10 mg/m2 twice daily for 7 days.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Venetoclax (ABT-199, GDC-0199) Decitabine (Dacogen, 5-aza-2-deoxycytidine) Azacitidine (5-Azacytidine, Ladakamycin) Cytarabine (Cytarabine hydrochloride)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged ≥18 years old, voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
2. The toxic and side effects caused by the last treatment should be recovered.
3. Eastern Cooperative Oncology Group score of 0 to 3 points.
4. The organ function is intact.

* Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5×ULN (Upper Limit of Normal).
* Creatinine≤1.5×ULN.
* Bilirubin≤1.5×ULN.
5. Karnofsky≥70.
6. The expected survival period is at least 12 weeks.
7. Non-pregnant, non-breastfeeding women.

Exclusion Criteria

1. Suffering from other untreated or unrelieved malignant tumors within 2 years.
2. Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
3. Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association \[NYHA\] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
4. Patients who are unwilling or unable to comply with the protocol.
5. Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
6. Women who are pregnant or breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No