AML (Acute Myelogenous LeukemiaPhase 1/2NCT07757672
Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by HSCT for R/R AML.
A Phase 1/2 study testing Sonrotoclax, cladribine, and standard-dose cytarabine in people with AML (Acute Myelogenous Leukemia and HSCT, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- AML (Acute Myelogenous Leukemia, HSCT
- What is being tested?
- Sonrotoclax, cladribine, and standard-dose cytarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Apr 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official 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
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?
Read more
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
- Being tested
- Sonrotoclax, cladribine, and standard-dose cytarabine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonrotoclax, cladribine, and standard-dose cytarabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| salvage treatment | Experimental | Salvage chemotherapy with Sonrotoclax, cladribine, and standard-dose cytarabine in patients with relapsed/refractory acute myeloid leukemia. Receives: Drug: Sonrotoclax, cladribine, and standard-dose cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
One year overall survival (OS) rate after treatment.
Measured: One year
Secondary outcomes (9)
Response rate (complete remission [CR] and complete remission with incomplete hematologic recovery [CRi]) after salvage chemotherapy
Measured: one month after chemotherapy
1-year relapse-free survival (RFS) rate
Measured: one year after treatment
1-year cumulative incidence of relapse (CIR)
Measured: one year after treatment
1-year treatment-related mortality (TRM) rate
Measured: one year after treatment
Rate of bridging to allogeneic hematopoietic stem cell transplantation
Measured: one year after treatment
Assessment of hematopoietic reconstitution post-transplantation
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.
Measured: One year after HSCT
Incidence and severity of graft-versus-host disease (GVHD)
Measured: One year
Rates of MRD-negative complete remission (CR<sub>MRD-</sub>) and MRD-negative complete remission with incomplete hematologic recovery (CRi<sub>MRD-</sub>)
Measured: one year after treatment
Treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: one year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757672
- Sponsor's protocol ID
- IIT2026039
- Status last verified
- Aug 2026
- First submitted
- 30 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No