TEAM-Trial: Overcoming the resistance to chemotherapy with the study drug Bortezomib in patients with akute myeloid leukemia : A multi-centre phase II Approach and evaluation with comparable patients
Phase 1
- Conditions
- Patients with confirmed diagnosis of Acute Myeloid Leukemia (AML)according to WHO-2016 classification (except acute promyelocytic leukemia) either de novo AML, AML after preceding myelodysplastic or myeloproliferative syndrome (MDS/MPD), and therapy related AML (t-AML) after previous cytotoxic therapy or radiation are eligible either refractory to first line chemotherapy or in first relapse, also after stem cell transplantation.Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2017-005158-12-DE
- Lead Sponsor
- Ruprecht-Karls-University Heidelberg Medical Faculty, University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
See protocol chapter 5.3
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
Exclusion Criteria
See protocol chapter 5.4
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method