NCT06651866 Dose-escalation Study of D-CMG Regimen for the Treatment of Elderly Newly Diagnosed AML Patients
| NCT ID | NCT06651866 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2024-12-12 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Bing Xu
PRINCIPAL INVESTIGATOR
The First Aiffiliated hosptical of xiamen University
Frequently Asked Questions
Who can join the NCT06651866 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 75 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06651866 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06651866 currently recruiting?
Yes, NCT06651866 is actively recruiting participants. Contact the research team at xubingzhangjian@126.com for enrollment information.
Where is the NCT06651866 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT06651866 clinical trial?
NCT06651866 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Bing Xu at The First Aiffiliated hosptical of xiamen University. The trial plans to enroll 18 participants.
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