Skip to content

CLAG in combination with PLD for refractory acute myeloid leukemia

CLAG in combination with PLD for refractory acute myeloid leukemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060082
Enrollment
Unknown
Registered
2022-05-18
Start date
2022-05-18
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Interventions

Experimental group:CLAG in conjunction with PLD

Sponsors

Department of Hematology, Second Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 and above; 2. Patients with AML who were insensitive to at least 2 cycles of induction chemotherapy or who relapsed early after remission of previous treatment or who received reinduction therapy at late relapse without remission; 3. ECGO physical condition score 0-2, or KPS score greater than 60; 4. The patient has not taken other cytotoxic drugs (other than hydroxyurea) within 2 weeks or has completed 5 half-lives since last taking the tested drug or non-cytotoxic drug; 5. Serum aspartate aminotransferase and alanine aminotransferase were lower than 2.5 times the upper limit of normal; 6. The total amount of serum bilirubin was lower than 1.5 times the upper limit of normal; 7. Serum creatinine below 1.5 times the upper normal limit or estimated glomerular filtration rate above 50 mL/min; 8. Voluntary informed consent.

Exclusion criteria

Exclusion criteria: 1. Critically ill patients with acute promyelocytic leukemia or chronic myelogenous leukemia; 2. Uncontrolled infection of the patient, immunodeficiency virus infection or hepatitis B, hepatitis C or other liver damage diseases; 3. Active stage malignancies that are not myelodysplastic syndromes or AML; 4. Patients with persistent non-hematologic toxicity grade greater than 2 who developed symptoms before treatment with AML; 5. Patients who have received hematopoietic stem cell transplantation for less than 2 months or suffer from graft-versus-host disease requiring treatment, and non-hematologic toxicity greater than or equal to grade 2 after transplantation; 6. Diffuse intravascular coagulation disorder; 7. Received major surgery or radiation therapy within 4 weeks before the study began; 8. Serious heart disease: including but not limited to unstable angina pectoris, myocardial infarction, severe arrhythmia, and congestive heart failure class 3-4 according to the New York Heart Association (NYHA).

Design outcomes

Primary

MeasureTime frame
Completely remission;Partial mitigation;Overall response rate;Negative rate of tiny residual lesions;Safety;

Secondary

MeasureTime frame
Overall survival;Progression-free survival;

Countries

China

Contacts

Public ContactQin Hui
qinhui6957@sina.com+86 13205515169

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026