Dose-escalation Study of D-CMG Regimen for the Treatment of Elderly Newly Diagnosed AML Patients

NCT ID: NCT06651866

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2027-06-30

Brief Summary

to observe the dose-limiting toxicity (DLT) of liposomal mitoxantrone hydrochloride injection combined with cytarabine and decitabine in the initial treatment of acute myeloid leukemia (AML), to explore the maximum tolerated dose (MTD) of the combined D-CMG regimen, and to evaluate its safety and efficacy

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

D-CMG

Liposomal mitoxantrone hydrochloride injection (Doxorubicin®): Used after dilution with 250mL of 5% glucose injection (50mg/mL), with an intravenous drip time of at least 60 minutes.

• Level 1: 12mg/m2, IV drip, day 4;
• Level 2: 18mg/m2, IV drip, day 4; Decitabine: 25mg, IV drip, days 1-3; Cytarabine: 10mg/m2, every 12 hours, IV drip, days 4-10; G-CSF: 300 ug, IV drip, days 1-5; Each cycle is 4 weeks, with a total of 2 cycles, and DLT is observed in the first cycle.

Note: Patients who achieve CR (Complete Remission) and PR (Partial Remission) in the first cycle can continue with the original dose for one more cycle, and then the investigator decides whether to continue this regimen or choose another regimen for maintenance therapy; Patients with NR (No Remission) in the first cycle will be withdrawn from this study.

Group Type: EXPERIMENTAL

D-CMG

Intervention Type: DRUG

Liposomal mitoxantrone hydrochloride injection (Doxorubicin®): Used after dilution with 250mL of 5% glucose injection (50mg/mL), with an intravenous drip time of at least 60 minutes.

• Level 1: 12mg/m2, IV drip, day 4;
• Level 2: 18mg/m2, IV drip, day 4; Decitabine: 25mg, IV drip, days 1-3; Cytarabine: 10mg/m2, every 12 hours, IV drip, days 4-10; G-CSF: 300 ug, IV drip, days 1-5; Each cycle is 4 weeks, with a total of 2 cycles, and DLT is observed in the first cycle.

Note: Patients who achieve CR (Complete Remission) and PR (Partial Remission) in the first cycle can continue with the original dose for one more cycle, and then the investigator decides whether to continue this regimen or choose another regimen for maintenance therapy; Patients with NR (No Remission) in the first cycle will be withdrawn from this study.

Interventions

D-CMG

Liposomal mitoxantrone hydrochloride injection (Doxorubicin®): Used after dilution with 250mL of 5% glucose injection (50mg/mL), with an intravenous drip time of at least 60 minutes.

• Level 1: 12mg/m2, IV drip, day 4;
• Level 2: 18mg/m2, IV drip, day 4; Decitabine: 25mg, IV drip, days 1-3; Cytarabine: 10mg/m2, every 12 hours, IV drip, days 4-10; G-CSF: 300 ug, IV drip, days 1-5; Each cycle is 4 weeks, with a total of 2 cycles, and DLT is observed in the first cycle.

Note: Patients who achieve CR (Complete Remission) and PR (Partial Remission) in the first cycle can continue with the original dose for one more cycle, and then the investigator decides whether to continue this regimen or choose another regimen for maintenance therapy; Patients with NR (No Remission) in the first cycle will be withdrawn from this study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed acute myeloid leukemia (non-M3) that has not been previously treated and cannot receive standard cytarabine and anthracycline induction therapy due to age, comorbidities, or patient preference.

2. Aged 60-75 years, both male and female, with an expected survival time of more than 3 months.

3. Estimated creatinine clearance rate ≥ 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 Performance Status ≤ 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. History of myeloproliferative neoplasms (MPN), including myelofibrosis, primary thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and AML with BCR-ABL1 translocation.

4. HIV-positive patients and/or active HBV or HCV infection (as documented by positive HBV-DNA and HCV-RNA tests).

5. Clinically significant QTc prolongation (men > 450 ms; women > 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block, history of myocardial infarction within the past year, congestive heart failure, and coronary artery disease requiring medication.

6. Active, uncontrolled severe infection.

7. History of other malignancies within the past 2 years, except for adequately treated in situ carcinoma of the cervix or breast; skin basal cell carcinoma or localized squamous cell carcinoma of the skin.

8. White blood cell count > 25 x 10^9/L. (This criterion can be met with hydroxyurea or leukapheresis.)

9. Mental impairment that would compromise the ability to participate in the study.

10. Any other situation in which the investigator believes that it would not be in the best interest of the patient to participate in the trial.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Bing, Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bing Xu

Role: PRINCIPAL_INVESTIGATOR

The First Aiffiliated hosptical of xiamen University

Locations

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bing Xu

Role: CONTACT

xubingzhangjian@126.com

18750918842

Facility Contacts

Bing Xu, phD

Role: primary

xubingzhangjian@126.com

Other Identifiers

XMDYYYXYK-14

Identifier Type: -

Identifier Source: org_study_id