Combination Salvage Therapy With Venetoclax and Decitabine in Relapsed/Refractory AML

Sponsor
University Hospital Tuebingen
Study ID
NCT06156579
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Decitabine — DRUG
    Decitabine 20 mg/m\^2, i.v., once daily, 10 days
  • Venetoclax — DRUG
    Venetoclax, 400 mg, p.o., once daily, 28 days

Study Details

The goal of this prospective, phase II single center, one arm, open label clinical trial is to test the efficacy and feasibility of a combination salvage therapy with Venetoclax and intensified Decitabine in patients with newly diagnosed AML (acute myeloid leukemia) and primary induction failure and patients with relapse of AML/MDS IB2 (myelodysplastic neoplasm with increased blasts 2) after chemotherapy. The primary endpoint is hematologic remission after treatment with Decitabine and Venetoclax. Participants eligible for the trial will receive a treatment of ten days of Decitabine and twenty-eight days of Venetoclax for one or two cycles, after which hematological remission will be assessed. Follow up will include the first one hundred days after end of treatment.

Key Dates

Start date
Nov 4, 2023
Status verified
Dec 2024
Primary completion
Sep 1, 2026
Completion
Mar 31, 2027

Study Design

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

Arms

  • Experimental: Treatment
    Salvage therapy with Venetoclax and intensified Decitabine

Primary Outcome Measure

Rate of hematological remissions [ Time Frame: measured after the first and second cycle (each cycle is 28 days) ]

Central Contacts

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