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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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. ).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

( 1 ) Acute lymphoblastic leukemia with positive Ph chromosome or BCR / ABL fusion gene ; after allogeneic hematopoietic stem cell transplantation, and survived for more than 30 days after transplantation.

Disqualifiers

( 1 ) Hematology remission was evaluated at 1 month after transplantation, and complete donor chimerism was achieved.

Trial design

Design model

Single group

Treatments tested in this trial

  • Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.

    Drug

    Olverembatinib is used to prevent recurrence or preemptive treatment after transplantation.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Olverembatinib as maintenance therapy or preemptive therapy post-HSCTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

2-year RFS after transplantation

2-year relapse-free survival after transplantation

Time frame
2 year after HSCT

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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