Actively Recruiting
Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML
Led by GWT-TUD GmbH · Updated on 2023-10-11
150
Participants Needed
28
Research Sites
367 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To compare the event-free survival at 2 years of CPX-351 vs. conventional care regimens before allogeneic blood cell transplantation as first line treatment in patients with higher risk MDS and oligoblastic AML.
CONDITIONS
Official Title
Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with high risk MDS including oligoblastic non-proliferative AML with up to 29% bone marrow blasts
- Bone marrow blast count of 5% or higher confirmed by central morphology
- Intermediate or high IPSS score
- Planned allogeneic stem cell transplantation within 6 months
- ECOG performance status of 0 or 1
- Signed informed consent
- Kidney function with serum creatinine less than 2.0 mg/dL
- Liver function with total bilirubin less than 2.0 mg/dL
- Liver enzymes (ALT or AST) less than 3 times the upper limit of normal
- Cardiac ejection fraction of 50% or higher by echocardiography
- Female participants of childbearing potential agree to use medically accepted contraception starting 2 months before treatment and continuing through 6 months after last dose
- Male participants agree to use adequate contraception during the study and for 6 months after the last dose
- Combined oral contraceptives are not recommended; two medically accepted contraception methods are advised
You will not qualify if you...
- History of myeloproliferative neoplasms or combined MDS/MPN
- Certain specific AML subtypes defined by WHO-2016 classification
- Active central nervous system leukemia
- Currently active second malignancy other than non-melanoma skin cancer
- Major surgery or radiation therapy within 4 weeks before screening
- Prior treatment with CPX-351, hypomethylating agents, cytarabine, or intensive chemotherapy for high-risk MDS or AML
- Cumulative anthracycline exposure over 368 mg/m2 daunorubicin or equivalent
- Serious medical, laboratory, or psychiatric conditions preventing consent
- Heart failure classified as NYHA class III or IV
- Active or uncontrolled infection; must be stable and afebrile for at least 72 hours if receiving treatment
- Current invasive fungal infection or known active hepatitis B, C, or HIV infection
- Hypersensitivity to cytarabine, daunorubicin, or liposomal products
- History of Wilson's disease or other copper metabolism disorders
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 28 locations
1
Ordensklinikum Linz Elisabethinen GmbH
Linz, Austria, 4020
Actively Recruiting
2
Uniklinikum Salzburg - Landeskrankenhaus
Salzburg, Austria, 5020
Withdrawn
3
Universitätsklinikum Aachen
Aachen, Germany, 52074
Actively Recruiting
4
Universitätsklinikum Augsburg
Augsburg, Germany, 86156
Actively Recruiting
5
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12200
Actively Recruiting
6
Helios Klinikum Berlin-Buch GmbH
Berlin, Germany, 13125
Actively Recruiting
7
Universitätsklinikum Bonn (UKB)
Bonn, Germany, 53127
Actively Recruiting
8
Klinikum Chemnitz-gGmbH
Chemnitz, Germany, 09113
Actively Recruiting
9
Universitätsklinikum Köln
Cologne, Germany, 50937
Actively Recruiting
10
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
11
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Actively Recruiting
12
Universitätsklinikum Essen
Essen, Germany, 45122
Actively Recruiting
13
Klinikum Frankfurt (Oder) GmbH
Frankfurt, Germany, 15236
Actively Recruiting
14
Universitätsklinikum Frankfurt
Frankfurt, Germany, 60590
Actively Recruiting
15
Universitätsklinikum Halle
Halle, Germany, 06120
Actively Recruiting
16
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
17
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
18
Universitätsklinikum Jena
Jena, Germany, 07740
Actively Recruiting
19
Gemeinschaftsklinikum Mittelrhein gGmbH
Koblenz, Germany, 56068
Actively Recruiting
20
Universitätsklinikum Leipzig AöR
Leipzig, Germany
Actively Recruiting
21
Universitätsmedizin Mannheim
Mannheim, Germany, 68167
Actively Recruiting
22
Klinikum rechts der Isar der TU München
München, Germany, 81675
Actively Recruiting
23
Universitätsklinikum Münster
Münster, Germany, 48149
Actively Recruiting
24
Klinikum Nürnberg
Nuremberg, Germany, 90419
Actively Recruiting
25
Universitätsmedizin Rostock
Rostock, Germany, 18055
Actively Recruiting
26
Robert-Bosch-Krankenhaus Stuttgart
Stuttgart, Germany, 70376
Actively Recruiting
27
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
28
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
Research Team
A
Arnold Schröder, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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