Actively Recruiting
Combination Salvage Therapy With Venetoclax and Decitabine in Relapsed/Refractory AML
Led by University Hospital Tuebingen · Updated on 2025-04-08
27
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination Salvage Therapy With Venetoclax and Decitabine in Relapsed/Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML according to WHO criteria regardless of subtype, including de novo and transformed MPN and transformed MDS
- Refractory to induction chemotherapy with Daunorubicin+Cytarabin ("3+7") or equivalent, including CPX351 and combinations with Gemtuzumab Ozogamicin or FLT3-inhibitors
- Refractory disease defined by specific bone marrow blast percentages at day 15 and day 28 of induction chemotherapy
- Relapse of AML or MDS IB2 after chemotherapy with at least 5% medullary blasts
- Age 18 years or older at informed consent
- Able to understand and voluntarily sign informed consent
- Able to follow study visit schedule and protocol requirements
- Fit for aggressive induction chemotherapy and transplantation as assessed by hematologist
- No known chronic pulmonary disease and absence of dyspnea; documented lung function with DLCO >40% and FEV1/FVC >50%
- Willingness to use highly effective birth control during and after treatment as specified
- Agreement to refrain from blood donation while on study drug and for 28 days after discontinuation
- Agreement not to share medication
You will not qualify if you...
- Acute promyelocytic leukemia (APL) with t(15;17)
- Refusal of chemotherapy
- Previous allogeneic stem cell transplantation
- ECOG performance status greater than 3
- Known hypersensitivity to Venetoclax, Decitabine, or their excipients
- Relapsed FLT3-ITD or FLT3-TKD mutated patients who previously responded to FLT3-inhibitor therapy
- Pregnancy or breastfeeding
- Significant active cardiac disease within 6 months prior to treatment, including NYHA class III/IV heart failure, recent myocardial infarction, unstable angina, stroke, severe arrhythmias, or LVEF <40%
- Severe obstructive or restrictive lung disease
- Symptoms or known involvement of central nervous system leukemia
- Uncontrolled active infections including hepatitis B, C, or HIV
- Life-threatening severe leukemia complications such as uncontrolled bleeding or disseminated intravascular coagulation
- Conditions impairing oral drug ingestion or absorption
- Active second malignancy unless therapy completed and relapse risk <30% within one year; exceptions include certain skin and cervical carcinomas and incidental prostate cancer
- Receipt of live attenuated vaccine within 30 days prior to study inclusion or planned during study and up to 6 months after therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
Research Team
L
Lucas Mix, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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