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NCT Number: NCT07757672

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 4. Pregnant patients, or patients who are unwilling or unable to use adequate contraceptive measures during the treatment period.
  • 5. Prior hematopoietic stem cell transplantation.
  • 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.
  • 8. Any other condition that, in the investigator's opinion, makes the patient ineligible for study participation.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: One year

Secondary outcomes

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

    Time frame: one month after chemotherapy

  2. 1-year relapse-free survival (RFS) rate

    Time frame: one year after treatment

  3. 1-year cumulative incidence of relapse (CIR)

    Time frame: one year after treatment

  4. 1-year treatment-related mortality (TRM) rate

    Time frame: one year after treatment

  5. Rate of bridging to allogeneic hematopoietic stem cell transplantation

    Time frame: one year after treatment

  6. Assessment of hematopoietic reconstitution post-transplantation

    Time frame: One year after HSCT

    Hematopoietic reconstitution refers to Neutrophil engraftment and platelet engraftment. Neutrophil engraftment was defined as the first of three consecutive days with an absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L. Platelet engraftment was defined as a platelet count ≥ 20 × 10⁹/L for seven consecutive days without platelet transfusion support.

  7. Incidence and severity of graft-versus-host disease (GVHD)

    Time frame: One year

  8. Rates of MRD-negative complete remission (CR<sub>MRD-</sub>) and MRD-negative complete remission with incomplete hematologic recovery (CRi<sub>MRD-</sub>)

    Time frame: one year after treatment

  9. Treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: one year after treatment

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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