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NCT06385808Not yet recruiting

Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML

Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Combined With Thiotepa, Busulfan and Fludarabine Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in Relapsed or Refractory Acute Myeloid Leukemia

Source: ClinicalTrials.gov · Last updated 26 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
37 (estimated)
First submitted
23 Apr 2024
Start date
1 May 2024
Primary completion date
31 Dec 2026
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
NCT number
NCT06385808

What you commit to

  • Study type: Interventional
  • Planned participants: 37
  • From 1 May 2024 to the primary completion date, 31 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Hypersensitivity to any investigational drug or its components;

Other illness

  • Uncontrolled systemic diseases (e.g. active infections, uncontrolled hypertension, diabetes, etc.)
  • Active infection of hepatitis B and hepatitis C;
  • Human immunodeficiency virus (HIV) infection;
  • Patients with other malignant tumors;
  • History of drug abuse (non-medical use of narcotic drugs or psychotropic drugs) or history of drug dependence (sedative hypnotics, analgesics, narcotics, stimulants and psychotropic drugs, etc.);
  • History of mental illness or cognitive impairment;

Lab values

  • Cardiac function and disease meet one of the following conditions:
    • Long QTc syndrome or QTc interval\>480 ms;
    • Complete left bundle branch block, II or III degree atrioventricular block;
    • Serious and uncontrolled arrhythmia requiring drug treatment;
    • American New York Heart Association rating ≥ III degree;
    • Cardiac ejection fraction (LVEF) is less than 60%;
    • History of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or He has any arrhythmia requiring treatment, clinical history of serious pericardial disease, or acute ischemia or activity ECG evidence of abnormal conduction system;

Other

  • Other investigators determined that participation in this study was not appropriate.

Who the study is looking for

  • The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up;
  • Age 18-65 years old (including upper and lower limits);
  • No gender limitation
  • Relapsed or refractory (R/R) acute myeloid leukemia can not achieve complete remission by chemotherapy, and has the indication of salvage allogeneic hematopoietic stem cell transplantation.
  • R/R AML was defined as: ① Initial treatment cases that failed after 2 courses of standard chemotherapy; ② After CR consolidation and intensive treatment, relapse within 12 months; ③ Recurred 12 months later, but conventional chemotherapy was ineffective; ④ Two or more relapses; ⑤ Extramedullary leukemia persists; ⑥Leukemia cells in peripheral blood or the proportion of bone marrow original cells \>0.050 or the occurrence of extramedullary leukemia cell infiltration after CR.
  • Could tolerate allogeneic hematopoietic stem cell transplantation.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.