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

NCT06385808 | Not Yet Recruiting

• 1 other identifier: XJTU1AF-CRF-2023-XK014
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Relapse Leukemia; Refractory Acute Myeloid Leukemia; Conditioning; Hematopoietic Stem Cell Transplantation

Keywords

relapsed or refractory acute myeloid leukemia; conditioning regimen; allogeneic hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  Disease activity in patients after transplantation

  2 years post transplantation

Secondary Outcomes (5)

• Incidence and Severity of non-hematological adverse events (NCI CTCAE v5.0)

  from the beginning of the conditioning regimen to 2 years post transplantation

• Neutrophil recovery time

  1 month post transplantation

• Platelet recovery time

  1 month post transplantation

• OS

  From date of diagnosis until the end of follow-up or the date of death from any couse. Time rage: 6 months post transplantation, 12 months post transplantation.

• PFS

  From date of diagnosis until the end of follow-up or disease progression. Time rage: 6 months post transplantation, 12 months post transplantation.

Other Outcomes (1)

• aGVHD

  At day 100 post transplantation

Study Arms (1)

MTBF regimen group

EXPERIMENTAL

The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells.

Drug: MTBF regimen

Interventions

MTBF regimen DRUG

The subjects will be treated with mitoxantrone hydrochloride liposome combined with thiotepa, busulfan and fludarabine as conditioning regimen prior to allo-HSCT. Mitoxantrone hydrochloride liposome 24mg/m\^2 ivgtt d-7; Ctepide 5mg/kg ivgtt d-6\~-5; Busulfan 0.8mg/kg q6h ivgtt d-4\~-2; Fludarabine 50mg/m\^2 ivgtt d-4\~-2.

Also known as: Mitoxantrone Hydrochloride Liposome, Thiotepa, Busulfan, Fludarabine

MTBF regimen group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hypersensitivity to any investigational drug or its components;
• Uncontrolled systemic diseases (e.g. active infections, uncontrolled hypertension, diabetes, etc.)
• 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;
• 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;
• Other investigators determined that participation in this study was not appropriate.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Interventions

Thiotepa; Busulfan; fludarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Xiaoning Wang, M.D.

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoning Wang, M.D.

CONTACT

0086-18991232608; wangxn99@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells. The one-year recurrence-free survival after transplantation of these patients and the safty of the MTBF regimen will be studied.

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04