Veneclax, Chidaniline Combined With Azacitidine Followed by Decitabine + MAG Regimen in the Treatment of Elderly Untreated AML

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

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2027-06-30

Brief Summary

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A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)

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Detailed Description

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A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)

Group Type EXPERIMENTAL

veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)

Intervention Type DRUG

Specified dose on specified days

Interventions

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veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG)

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histologically confirmed acute myeloid leukemia (non-M3). Have not received treatment before and cannot accept standard cytarabine and anthracycline induction regimen treatment due to age or comorbidity or patient preference;
2. Age \>= 60 years old, male or female, expected survival time greater than 3 months;
3. Estimated creatinine clearance \>= 30 mL/min;
4. AST and ALT \<= 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin \<= 1.5 x ULN (unless considered due to leukemic organ involvement);
5. ECOG \<= 2;
6. Able to understand and voluntarily provide informed consent.

Exclusion Criteria

1. Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16);
2. Active central nervous system leukemia;
3. A history of myeloproliferative neoplasms (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myelogenous leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR- ABL1 translocation;
4. HIV-positive patients and/or HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive tests);
5. Suffering from chronic respiratory diseases requiring continuous oxygen inhalation, or having an obvious history of kidney, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases;
6. Suffering from malabsorption syndrome or other diseases that exclude the enteral route of administration;
7. Clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction, and congestive heart failure within one year before enrollment patients, and patients with coronary heart disease who have clinical symptoms and need drug treatment;
8. Active, uncontrolled severe infection;
9. There is a history of other malignant tumors within 2 years, except for the following cases: adequately treated carcinoma in situ of the cervix or carcinoma in situ of the breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
10. White blood cell count \> 25 x 10\^9/L (hydroxyurea or leukapheresis can meet this standard);
11. Mental disorders that will hinder research participation;
12. Participants have received the following treatments: hypomethylation agents, venetoclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation;
13. Any other circumstances that the investigator believes that the patient is not suitable to participate in this trial.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No