NCT07757672Not yet recruitingPhase 1/2
Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by HSCT for R/R AML.
A Prospective Phase II Clinical Trial of Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed/Refractory Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
The goal of this clinical trial is to treat adult patients with relapsed/refractory acute myeloid leukemia (AML) using a salvage chemotherapy regimen consisting of Sonrotoclax, cladribine, and standard-dose cytarabine, sequentially followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are: Does this treatment regimen improve the 2-year overall survival (OS) rate, relapse-free survival (RFS) rate, and cumulative incidence of relapse (CIR) in this patient population? What is the safety profile of this combination and sequential transplant strategy, particularly regarding treatment-related mortality (TRM) and adverse events? As this is a single-arm phase II study, there is no comparator group. Participants will: Receive salvage chemotherapy with cladribine (5 mg/m² on days 1-5), cytarabine (100 mg/m² twice daily on days 1-5), and Sonrotoclax (escalating doses from 40 mg to 320 mg on days 1-14). Undergo allogeneic hematopoietic stem cell transplantation as a bridge therapy within 1 to 4 weeks after completing chemotherapy. Potentially receive Sonrotoclax as maintenance therapy after hematopoietic reconstitution post-transplant, at the investigator's discretion. Undergo regular follow-up visits for clinical assessments, disease monitoring, and survival evaluation.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07757672
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 50
- From Sept 2026 to the primary completion date, Apr 2029
- 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
- 5\. Prior hematopoietic stem cell transplantation.
Other illness
- 1\. Uncontrolled active infection (bacterial, fungal, or viral).
- 2\. Known positive serology for human immunodeficiency virus (HIV) or active hepatitis C virus (HCV).
- 3\. Psychiatric disorders or other medical conditions that preclude compliance with the study treatment and monitoring requirements.
- 8\. Any other condition that, in the investigator's opinion, makes the patient ineligible for study participation.
Lab values
- 6\. Active cardiac disease, defined as one or more of the following: History of uncontrolled or symptomatic angina pectoris; Myocardial infarction within 6 months prior to study enrollment; History of arrhythmia requiring medication or clinically significant symptomatic arrhythmia; Uncontrolled or symptomatic congestive heart failure (\> New York Heart Association \[NYHA\] class 2); Ejection fraction below the lower limit of normal; Previous coronary angioplasty or stent implantation.
- 7\. Severe hepatic impairment, defined as liver function parameters (ALT, TBIL) \> 3 × upper limit of normal (ULN); or severe renal impairment, defined as serum creatinine (Cr) \> 2 × ULN, or 24-hour urine creatinine clearance \< 50 mL/min; or any other condition that, in the investigator's opinion, renders the patient unsuitable for treatment with the study drug.
Other
- 4\. Pregnant patients, or patients who are unwilling or unable to use adequate contraceptive measures during the treatment period.
Who the study is looking for
- 1.Patients with a confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) based on bone marrow morphology, immunophenotyping, and cytogenetics.
- 2\. Patients who are planned to undergo allogeneic hematopoietic stem cell transplantation, including HLA-matched or HLA-mismatched related allogeneic transplantation, as well as unrelated donor transplantation.
- 3\. Age between 18 and 65 years, inclusive, regardless of gender.
- 4\. Eastern Cooperative Oncology Group performance status (ECOG) of 0-2.
- 5\. Written informed consent must be obtained prior to the initiation of any study-related procedures. For patients aged 18 years or older, the consent form may be signed by the patient or by a direct relative. Should the patient's own signature be judged to be potentially harmful to their clinical care, consent may instead be given by a legal guardian or a direct relative.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.