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

NCT07757672 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-11

No results posted yet for this study

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

Interventions

DRUG

Sonrotoclax, cladribine, and standard-dose cytarabine

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-04-30
Completion
2029-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757672 on ClinicalTrials.gov