Actively Recruiting
Phase II Study of Early Combination Salvage Therapy With Venetoclax and Intensified Decitabine in Relapsed/Refractory AML
Led by University Hospital Tuebingen · Updated on 2025-04-08
27
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination salvage therapy using Venetoclax and intensified Decitabine for patients with newly diagnosed acute myeloid leukemia (AML) who have not responded to initial chemotherapy, as well as those with relapsed AML or myelodysplastic neoplasm with increased blasts (MDS IB2) after chemotherapy. This phase II clinical trial aims to assess the effectiveness and feasibility of this treatment approach, focusing primarily on achieving hematologic remission. The study also explores altering treatment from chemotherapy to epigenetic and anti-BCL2 therapies in this patient group. Participants will receive ten days of Decitabine administered intravenously once daily at 20 mg/m², combined with twenty-eight days of daily oral Venetoclax at 400 mg. Patients will undergo one or two treatment cycles, each lasting 28 days, with hematologic remission assessed after each cycle. If remission is not achieved after the first cycle, a second cycle may be given. Following treatment, participants will be monitored during a 100-day follow-up period to evaluate outcomes and safety. Throughout the study, participants will have regular evaluations including blood tests, bone marrow assessments, and quality of life questionnaires. Researchers will monitor remission rates, adverse events, infection rates, hematopoietic recovery, transplant timings, survival, and other health indicators. Safety will be assessed early in the trial after treating a small group of patients, with ongoing monitoring during treatment and follow-up. The total participation duration includes treatment cycles plus the 100-day observation after therapy.
CONDITIONS
Brief 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, including de novo and transformed MPN and transformed MDS
- Refractory to induction chemotherapy with Daunorubicin+Cytarabin or similar regimens
- Relapse of AML or MDS IB2 after chemotherapy with ≥5% medullary blasts
- Age 18 years or older at time of informed consent
- Ability to understand and voluntarily sign informed consent
- Ability to adhere to study visit schedule and protocol requirements
- Fit for aggressive induction chemotherapy and transplantation by hematologist assessment
- No known chronic pulmonary disease or dyspnea; lung function DLCO >40% and FEV1/FVC >50%
- Willingness to use highly effective birth control during treatment and for months after
- Agreement to refrain from blood donation during and 28 days after study treatment
- Agreement not to share medication
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL) with t(15;17)
- Refusal to consent to chemotherapy
- Previous treatment with allogeneic stem cell transplantation
- ECOG performance status greater than 3
- Hypersensitivity to Venetoclax, Decitabine, or excipients
- Relapsed FLT3-ITD or FLT3-TKD mutated patients previously responding to FLT3-inhibitor regimens
- Pregnancy or lactation
- Significant active cardiac disease within 6 months prior to study start
- Severe obstructive or restrictive lung disease
- Active central nervous system leukemia or symptoms suggestive of it
- Uncontrolled active infections including hepatitis B, C, or HIV
- Immediate life-threatening leukemia complications such as uncontrolled bleeding
- Conditions limiting ingestion or absorption of oral drugs
- Currently active second malignancy except certain skin or cervical cancers
- Receipt of live attenuated vaccine within 30 days prior to study inclusion and during study until 6 months after therapy end
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 56 days (two 28-day cycles)
Participants receive combination therapy with Venetoclax daily for 28 days and Decitabine daily for 10 days. If remission is not achieved after the first cycle, a second cycle may be given.
Visits during each 28-day treatment cycle as scheduled by the study
Duration - 100 days
Participants are monitored for safety, efficacy, and survival outcomes for 100 days after treatment completion.
Approximately 6 post-treatment visits
Trial Site Locations
Total: 1 location
1
University Hospital
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
Research Team
L
Lucas Mix, Dr.
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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