Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by HSCT for R/R AML.

NCT07757672 | Not Yet Recruiting Phase 1

• 1 other identifier: IIT2026039
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

AML (Acute Myelogenous Leukemia; HSCT

Outcome Measures

Primary Outcomes (1)

• One year overall survival (OS) rate after treatment.

  One year

Secondary Outcomes (9)

• Response rate (complete remission [CR] and complete remission with incomplete hematologic recovery [CRi]) after salvage chemotherapy

  one month after chemotherapy

• 1-year relapse-free survival (RFS) rate

  one year after treatment

• 1-year cumulative incidence of relapse (CIR)

  one year after treatment

• 1-year treatment-related mortality (TRM) rate

  one year after treatment

• Rate of bridging to allogeneic hematopoietic stem cell transplantation

  one year after treatment

Study Arms (1)

salvage treatment

EXPERIMENTAL

Salvage chemotherapy with Sonrotoclax, cladribine, and standard-dose cytarabine in patients with relapsed/refractory acute myeloid leukemia.

Drug: Sonrotoclax, cladribine, and standard-dose cytarabine

Interventions

Sonrotoclax, cladribine, and standard-dose cytarabine DRUG

After enrollment, patients will receive salvage chemotherapy with Sonrotoclax, cladribine, and standard-dose cytarabine, and will be bridged to allogeneic hematopoietic stem cell transplantation within 1 to 4 weeks after completion of chemotherapy. Following hematopoietic reconstitution post-transplantation, Sonrotoclax may be administered as maintenance therapy at the investigator's discretion.

salvage treatment

Eligibility Criteria

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

You may qualify if:

• Patients with a confirmed diagnosis of relapsed or refractory acute myeloid leukemia (AML) based on bone marrow morphology, immunophenotyping, and cytogenetics.
• \. 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.
• \. Age between 18 and 65 years, inclusive, regardless of gender.
• \. Eastern Cooperative Oncology Group performance status (ECOG) of 0-2.
• \. 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.

You may not qualify if:

• \. Uncontrolled active infection (bacterial, fungal, or viral).
• \. Known positive serology for human immunodeficiency virus (HIV) or active hepatitis C virus (HCV).
• \. Psychiatric disorders or other medical conditions that preclude compliance with the study treatment and monitoring requirements.
• \. Pregnant patients, or patients who are unwilling or unable to use adequate contraceptive measures during the treatment period.
• \. Prior hematopoietic stem cell transplantation.
• \. 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.
• \. 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.
• \. Any other condition that, in the investigator's opinion, makes the patient ineligible for study participation.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cladribine; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08