BridgeMD
A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of midostaurin to 10-day decitabine in unfit (i.e. HCT-CI ≥ 3) adult AML and high-risk myelodysplasia (MDS) (IPSS-R > 4.5) patients. A study in the frame of the masterprotocol of parallel randomized phase II studies in UNFIT- AML/high-risk MDS patients.
EU CTIS ID: 2023-503829-18-00
What this study is testing
To assess in a randomized comparison the effect of midostaurin added to 10-day decitabine treatment on the cumulative CR/CRi rate during 3 cycles
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- A diagnosis of AML and related precursor neoplasms according to WHO 2016 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or a diagnosis of myelodysplastic syndrome with excess of blasts (MDS) and IPSS-R > 4.5
- Patients 18 years and older
- Patients NOT eligible for standard chemotherapy, defined as HCT-CI ≥ 3. (Appendix G) or Patients NOT eligible for standard chemotherapy for other reasons (wish of patient)
- WBC ≤ 30 x109/L (prior hydroxyurea allowed for a maximum of 5 days, stop 2 days before start decitabine treatment)
- Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values: Serum creatinine ≤ 221.7 µmol/L (≤ 2.5 mg/dL ), unless considered AML-related, Serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert’s syndrome, Alanine transaminase (ALT) ≤ 2.5 x ULN, unless considered AML-related
- WHO performance status 0, 1 or 2 (see Appendix D)
You likely can't join if
- Acute promyelocytic leukemia
- History of stroke or intracranial hemorrhage within 6 months prior to randomization
- Patient has a history of human immunodeficiency virus (HIV) or active infection with Hepatitis C or B
- Patients known to be pregnant
- Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance
- Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study
See the full eligibility criteria
Who can join
- A diagnosis of AML and related precursor neoplasms according to WHO 2016 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or a diagnosis of myelodysplastic syndrome with excess of blasts (MDS) and IPSS-R > 4.5
- Patients 18 years and older
- Patients NOT eligible for standard chemotherapy, defined as HCT-CI ≥ 3. (Appendix G) or Patients NOT eligible for standard chemotherapy for other reasons (wish of patient)
- WBC ≤ 30 x109/L (prior hydroxyurea allowed for a maximum of 5 days, stop 2 days before start decitabine treatment)
- Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values: Serum creatinine ≤ 221.7 µmol/L (≤ 2.5 mg/dL ), unless considered AML-related, Serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert’s syndrome, Alanine transaminase (ALT) ≤ 2.5 x ULN, unless considered AML-related
- WHO performance status 0, 1 or 2 (see Appendix D)
- Patient is willing and able to use adequate contraception during and until 5 months after the last protocol treatment
- Written informed consent
- Patient is capable of giving informed consent
What rules you out
- Acute promyelocytic leukemia
- History of stroke or intracranial hemorrhage within 6 months prior to randomization
- Patient has a history of human immunodeficiency virus (HIV) or active infection with Hepatitis C or B
- Patients known to be pregnant
- Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance
- Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study
- Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Acute leukemia's of ambiguous lineage according to WHO 2016
- Patient has symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement)
- Blast crisis of chronic myeloid leukemia
- Diagnosis of any previous or concomitant malignancy is an exclusion criterion except when the patient completed successfully treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 6 months prior to randomization OR except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
- Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period (≤ 5 days) with Hydroxyurea is allowed
- Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.
- Cardiac dysfunction as defined by: Myocardial infarction within the last 3 months of study entry, or reduced left ventricular function with an ejection fraction < 40% as measured by MUGA scan or echocardiogram or unstable angina or New York Heart Association (NYHA) grade IV congestive heart failure (see Appendix I) or unstable cardiac arrhythmias
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.