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NCT06658925

Olverembatinib as Maintenance Therapy or Preemptive Therapy After Allo-HSCT in Ph+ALL

Not yet recruiting Phase 2 Last updated 26 October 2024
What this trial tests

Phase 2 trial testing Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation. in Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) in 50 participants. Not yet recruiting.

Timeline
1 November 2024
Primary endpoint
31 August 2027
31 August 2027

Quick facts

Lead sponsorInstitute of Hematology & Blood Diseases Hospital, China
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment50
Start date1 November 2024
Primary completion31 August 2027
Estimated completion31 August 2027

Drugs / interventions tested

Conditions studied

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Who can join

18 and older, any sex, with Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) or HSCT. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a single-center, prospective, single-arm exploratory study. Ph + acute lymphoblastic leukemia patients treated with allogeneic hematopoietic stem cell transplantation were recruited from the Stem Cell Transplantation Center of the Hospital of Hematology, Chinese Academy of Medical Sciences. The number of patients is expected to be 50 cases. The enrolled patients plan to receive Olverembatinib as a post-transplant treatment regimen, including maintenance therapy to prevent recurrence and preemptive treatment. Hematopoietic reconstitution ( neutrophil \> 0.5 × 10 \^ 9 / L, platelet \> 50 × 10 \^ 9 / L ) was evaluated after enrollment. From 2 months to 3 months after transplantation, Olverembatinib 40 mg QOD was added for maintenance treatment until 2 years after transplantation. During maintenance treatment, Olverembatinib dose ( dose range 20 mg QOD to 40 mg QOD ) can be adjusted according to blood picture, biochemical index or other oral drugs ( triazole drugs, etc. ).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current and emerging maintenance strategies after stem cell transplantation in children and adolescents with acute leukemias.
    Rankin AW, Keating AK, Abu-Arja RF, Thakar MS, et al · · 2026 · PMID 41716469 · DOI 10.1016/j.omton.2026.201141
  2. Olverembatinib (HQP1351): a third-generation tyrosine kinase inhibitor in the treatment of hematologic and solid malignancies-a comprehensive review of clinical outcomes.
    Sadati S, Yazdizadeh S, Razavi SM, Homayoonfal M, et al · · 2026 · PMID 41547674 · DOI 10.1007/s12672-026-04438-x

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Trials by the same sponsor.

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