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A single-arm, open, multicenter clinical study of Palbociclib in combination with Venetoclax and Azacitidine regimen (VAP regimen) for the treatment of NUP98-R positive childhood acute myeloid leukemia

A single-arm, open, multicenter clinical study of Palbociclib in combination with Venetoclax and Azacitidine regimen (VAP regimen) for the treatment of NUP98-R positive childhood acute myeloid leukemia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074396
Enrollment
Unknown
Registered
2023-08-04
Start date
2023-01-21
Completion date
Unknown
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myelocytic leukemia

Interventions

Experimental group:Palbociclib in combination with Venetoclax and Azacitidine

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.A clear diagnosis of AML. 2.Age 0-18 years. 3.Primary patients with positive NUP98-R fusion gene who are not in remission after one course of chemotherapy. 4.Refractory or relapsed patients with positive NUP98-R fusion gene. 5.Obtain the consent of the child or/and guardian and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Acute promyelocytic leukemia. 2.AML transformed by MDS. 3.AML secondary to Fanconi anemia. 4.AML secondary to Kostmanne's syndrome. 5.AML secondary to Shwachman syndrome. 6.AML secondary to other bone marrow failure disorders. 7.Only temporary chemotherapy or immunotherapy, without receiving systemic treatment in accordance with the treatment protocol. 8.With any significant abnormalities of coexisting diseases or psychiatric disorders that affect the patient's life safety and compliance, informed consent, study participation, follow-up or interpretation of result

Design outcomes

Primary

MeasureTime frame
Remission rate after one course of VAP regimen treatment;

Secondary

MeasureTime frame
MRD levels after one course of VAP regimen treatment;Remission rate and MRD level after two courses of VAP regimen treatment;Recurrence rate within three years after remission;Three year overall survival and event free survival;

Countries

China

Contacts

Public ContactRunming Jin

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

jinrunm@qq.com+86 27 8535 0744

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026