RecruitingPhase 2NCT04061239

Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML

Primary Comparison of Liposomal Anthracycline Based Treatment Versus Conventional Care Strategies Before Allogeneic Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML

Sponsor

GWT-TUD GmbH

Enrollment

150 participants

Start Date

Aug 19, 2019

Study Type

INTERVENTIONAL

Conditions

AML MDS

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (called PALOMA) compares a drug called CPX-351 — a liposomal formulation of two chemotherapy agents — to standard treatment approaches (such as azacitidine or standard chemotherapy) as a bridge to stem cell transplantation for adults with higher-risk myelodysplastic syndrome (MDS) or low-blast-count acute myeloid leukemia (AML). These blood cancers can be difficult to treat, and the goal is to find which approach best prepares patients for transplant with the highest chance of long-term benefit. Adults aged 18 to 75 with a confirmed diagnosis of higher-risk MDS or oligoblastic AML who have adequate organ function and a transplant planned within 6 months may be eligible. Participation involves receiving CPX-351 or a standard treatment regimen, followed by allogeneic stem cell transplantation and regular follow-up assessments for 2 years. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCPX-351

CPX-351 is a liposomal formulation with a fixed 5:1 molar ratio of cytarabine and daunorubicin. It will be administered as a 90-minute intravenous infusion.

DRUGDaunorubicin

Daunorubicin is commercially available as a powder for reconstitution in 20 mg vials. In this trial, daunorubicin should be administered as an IV infusion over 60 min.

DRUGCytarabine

Cytarabine is commercially available as vials/bottles for preparation of diluted infusion solution. Cytarabine will be administrated intravenously. In this trial, cytarabine is administered as a continuous infusion.

DRUGAzacitidine

Azacitidine at 75mg/m² for 7 days. Patients should receive a minimum of 2 and up to 6 cycles.

Locations(28)

Ordensklinikum Linz Elisabethinen GmbH

Linz, Austria

Uniklinikum Salzburg - Landeskrankenhaus

Salzburg, Austria

Universitätsklinikum Aachen

Aachen, Germany

Universitätsklinikum Augsburg

Augsburg, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Helios Klinikum Berlin-Buch GmbH

Berlin, Germany

Universitätsklinikum Bonn (UKB)

Bonn, Germany

Klinikum Chemnitz-gGmbH

Chemnitz, Germany

Universitätsklinikum Köln

Cologne, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Essen

Essen, Germany

Klinikum Frankfurt (Oder) GmbH

Frankfurt, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Universitätsklinikum Halle

Halle, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitätsklinikum Jena

Jena, Germany

Gemeinschaftsklinikum Mittelrhein gGmbH

Koblenz, Germany

Universitätsklinikum Leipzig AöR

Leipzig, Germany

Universitätsmedizin Mannheim

Mannheim, Germany

Klinikum rechts der Isar der TU München

München, Germany

Universitätsklinikum Münster

Münster, Germany

Klinikum Nürnberg

Nuremberg, Germany

Universitätsmedizin Rostock

Rostock, Germany

Robert-Bosch-Krankenhaus Stuttgart

Stuttgart, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, Germany

View Full Details on ClinicalTrials.gov

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NCT04061239

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