Clinical Study Protocol for the Treatment of ND-AML and RR-AML With KMT2A Gene Abnormalities Using VHEA.

Sponsor
Huai'an First People's Hospital
Study ID
NCT06328179
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a clinical trial aimed at evaluating the efficacy and safety of the VHEA（Venetoclax with Homoharringtonine，Etoposide，Cytarabine）regimen in the treatment of newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) with MLL gene abnormalities. This study includes the induction and consolidation phases of AML treatment.

Key Dates

Start date
May 24, 2022
Status verified
Mar 2024
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VHEA regimen in the treatment of ND-AML and RR-AML with MLL gene abnormalities.
    Venetoclax 100 mg d1，200 mg d2，400 mg d3-14； homoharringtoine, HHT 2 mg/m2，qd，d1-7； Etoposide 0.1 g，qd，d1-5； Cytarabine 100 mg/m2，qd，d1-7 The patient meets the criteria for autologous hematopoietic stem cell transplantation (ASCT) during the treatment process, they can undergo ASCT.If the patient meets the criteria for transplantation and there is a suitable donor, they can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Primary Outcome Measure

Overall response rate，ORR [ Time Frame: The period of 1 year from the start of treatment. ]

Central Contacts

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