Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics

November 15, 2023 updated by: Verena Gaidzik, University of Ulm

Randomized Phase III Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics

The trial is a randomized, open-label phase III study comparing CPX-351 vs conventional intensive induction and consolidation chemotherapy in patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification. Overall survival (OS) in the restricted set of de novo patients will be the primary endpoint.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

882

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Medizinische Universität Graz
        • Contact:
          • Armin Zebisch, MD
      • Innsbruck, Austria, 6020
        • Recruiting
        • Tirol Kliniken GmbH Innsbruck
        • Contact:
          • David Nachbaur, MD
      • Linz, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH, Elisabethinen
        • Contact:
          • Sigrid Machherndl-Spandl, MD
      • Rankweil, Austria, 6830
        • Recruiting
        • Feldkirch, Landeskrankenhaus
        • Contact:
          • Bernd Hartmann, MD
      • Salzburg, Austria, 5020
        • Recruiting
        • Landeskrankenhaus Salzburg
        • Contact:
          • Richard Greil, MD
      • Wien, Austria, 1140
        • Recruiting
        • Hanuschkrankenhaus Wien
        • Contact:
          • Elisabeth Koller, MD
  • Germany
      • Aschaffenburg, Germany, 63739
        • Recruiting
        • Klinikum Aschaffenburg
        • Contact:
          • Manfred Welslau, MD
        • Contact:
          • Simone Liebler, MD
      • Bad Saarow, Germany, 15526
        • Recruiting
        • HELIOS Klinikum Bad Saarow
        • Contact:
          • Daniel Schöndube, MD
        • Contact:
          • Richard Ratai, MD
        • Sub-Investigator:
          • Janina Bertz-Lepel, MD
      • Berlin, Germany, 10117
        • Recruiting
        • Berlin Charite - Campus Charite Mitte
        • Contact:
          • Jörg Westermann, MD
        • Contact:
          • Philipp Le Coutre, MD
        • Sub-Investigator:
          • Uwe Pelzer, MD
      • Berlin, Germany, 10967
        • Recruiting
        • Vivantes Klinikum Am Urban
        • Contact:
          • Christian Scholz, MD
        • Contact:
          • Annette Dieing, MD
      • Berlin, Germany, 12200
        • Recruiting
        • Berlin Charite - Campus Benjamin Franklin
        • Contact:
          • Jörg Westermann, MD
        • Contact:
          • Jan Krönke, MD
        • Sub-Investigator:
          • Klaus A Nogai, MD
      • Berlin, Germany, 12351
        • Recruiting
        • Vivantes Klinikum Neukölln
        • Contact:
          • Maike de Witt, MD
        • Contact:
          • Lore Marretta, MD
      • Berlin, Germany, 13353
        • Recruiting
        • Charite Berlin
        • Contact:
          • Jörg Westermann, MD
        • Contact:
          • Anne Flörcken, MD
      • Bochum, Germany, 44791
        • Recruiting
        • Bochum, Augusta-Kranken-Anstalt
        • Contact:
          • Stefan Lukic, MD
        • Contact:
          • Robert Radkowski, MD
      • Bochum, Germany, 44892
        • Recruiting
        • Knappschaftskrankenhaus Bochum-Langendreer
        • Contact:
          • Roland Schroers, MD
        • Contact:
          • Deepak Ben Vangala, MD
      • Bonn, Germany, 53105
        • Recruiting
        • Universitatsklinikum Bonn
        • Contact:
          • Teichmann Lino, MD
        • Contact:
          • Katjana S Schwab, MD
      • Braunschweig, Germany, 38114
        • Recruiting
        • Städtisches Klinikum Braunschweig gGmbH
        • Contact:
          • Jürgen Krauter, MD
        • Contact:
          • Carsten Springer, MD
      • Bremen, Germany, 28177
        • Recruiting
        • Klinikum Bremen-Mitte
        • Contact:
          • Bernd Hertenstein, MD
        • Contact:
          • Stephan Kaun, MD
      • Darmstadt, Germany, 64283
        • Recruiting
        • Klinikum Darmstadt
        • Contact:
          • Helga Bernhard, MD
        • Contact:
          • Stephan Schäfer, MD
      • Dortmund, Germany, 44137
        • Recruiting
        • St.-Johannes-Hospital
        • Contact:
          • Darina Kodzhabasheva, MD
        • Contact:
          • Ralf Georg Meyer, MD
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Universitätsklinikum Düsseldorf
        • Contact:
          • Ulrich Germing, MD
        • Contact:
          • Kathrin Nachtkamp, MD
        • Sub-Investigator:
          • Thomas Ulrych, MD
      • Essen, Germany, 45239
        • Recruiting
        • Kliniken Essen Süd, Ev. Krankenhaus Essen- Werden gGmbH
        • Contact:
          • Stephanie von Harsdorf, MD
        • Contact:
          • Peter Reimer, MD
      • Esslingen, Germany, 73730
        • Recruiting
        • Klinikum Esslingen
        • Contact:
          • Swen Wessendorf, MD
        • Contact:
          • Guido Hausner, MD
      • Flensburg, Germany, 24939
        • Recruiting
        • Malteser Krankenhaus St. Franziskus-Hospital
        • Contact:
          • Milena Milovanovic, MD
        • Contact:
          • Angela Krackhardt, MD
      • Freiburg, Germany, 79106
        • Recruiting
        • Universitatsklinikum Freiburg
        • Contact:
          • Michael Lübbert, MD
        • Contact:
          • Ralph Wäsch, MD
      • Gießen, Germany, 35392
        • Recruiting
        • Universitätsklinikum Gießen
        • Contact:
          • Mathias Rummel, MD
        • Contact:
          • Maisun Abu Samra, MD
      • Goch, Germany, 47574
        • Recruiting
        • Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital gGmbH Goch
        • Contact:
          • Volker Runde, MD
        • Contact:
          • Jörn Westheider, MD
      • Greifswald, Germany, 17475
        • Recruiting
        • Universitätsmedizin Greifswald
        • Contact:
          • Christian Späth, MD
        • Contact:
          • Claudia Moskwa, MD
      • Hamburg, Germany, 22763
        • Recruiting
        • Asklepios Klinik Altona
        • Contact:
          • Hans Salwender, MD
        • Contact:
          • Johanna Wilmsen, MD
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
        • Contact:
          • Walter Fiedler, MD
        • Contact:
          • Winfried H Alsdorf, MD
      • Hamburg, Germany, 20099
        • Recruiting
        • Asklepios Kliniken Hamburg GmbH St. Georg
        • Contact:
          • Ahmet Elmaagacli, MD
        • Contact:
          • Anju Singh, MD
      • Hamm, Germany, 59063
        • Recruiting
        • Evangelisches Krankenhaus Hamm gGmbH
        • Contact:
          • Alexander Baraniskin, MD
        • Contact:
          • Andrea Stoltefuß, MD
        • Sub-Investigator:
          • Andrea Stoltefuß, MD
      • Hannover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Felicitas Thol, MD
        • Contact:
          • Michael Heuser, MD
        • Sub-Investigator:
          • Christian Könecke, MD
      • Hannover, Germany, 30459
        • Recruiting
        • Klinikum Region Hannover - Klinikum Siloah
        • Contact:
          • Daniela Dörfel, MD
        • Contact:
          • Martin Müller, MD
        • Sub-Investigator:
          • Kim Marienhagen, MD
      • Heilbronn, Germany, 74078
        • Recruiting
        • SLK-Kliniken GmbH Heilbronn
        • Contact:
          • Markus Lindauer, MD
        • Contact:
          • Uwe Martens, MD
      • Herne, Germany, 44625
        • Recruiting
        • Marienhospital Herne, Klinikum der Ruhr
        • Contact:
          • Dirk Strumberg, MD
        • Contact:
          • Marta Litter, MD
      • Kaiserslautern, Germany, 67655
        • Recruiting
        • Kaiserslautern, Westpfalz-Klinikum
        • Contact:
          • Gerhard Held, MD
        • Contact:
          • Milena Pfeifer, MD
      • Karlsruhe, Germany, 76133
        • Recruiting
        • Städtisches Klinikum Karlsruhe gGmbH
        • Contact:
          • Mark Ringhoffer, MD
        • Contact:
          • Lukas Kündgen, MD
      • Lemgo, Germany, 32657
        • Recruiting
        • Klinikum Lippe-Lemgo
        • Contact:
          • Breuch Philipp, MD
        • Contact:
          • Frank Hartmann, MD
      • Ludwigshafen, Germany, 67063
        • Recruiting
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
        • Contact:
          • Peter Paschka, MD
        • Contact:
          • David Klank, MD
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein
        • Contact:
          • Friedericke Wortmann, MD
        • Contact:
          • Hellen Sievert
      • Lüdenscheid, Germany, 58515
        • Recruiting
        • Klinikum Lüdenscheid
        • Contact:
          • Monika Schwalenberg, MD
        • Contact:
          • Lars Petersen, MD
      • Magdeburg, Germany, 39120
        • Recruiting
        • Universitätsklinikum Magdeburg
        • Contact:
          • Martin Mikusko, MD
        • Contact:
          • Vanja Zeremski, MD
      • Mainz, Germany, 55131
        • Recruiting
        • Klinikum der Johannes Gutenberg Universität
        • Contact:
          • Michael Kühn, MD
        • Contact:
          • Markus Radsak, MD
      • Meschede, Germany, 59872
        • Recruiting
        • Klniikum Hochsauerland GmbH
        • Contact:
          • Mohammad Wattad, MD
        • Contact:
          • Barbara Wenning, MD
      • Minden, Germany, 32429
        • Recruiting
        • Johannes Wesling Klinikum Minden
        • Contact:
          • Hans Joachim Tischler, MD
        • Contact:
          • Kai Wille, MD
      • München, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar München
        • Contact:
          • Katharina Nickel, MD
        • Contact:
          • Katharina Götze, MD
      • Offenbach, Germany, 63069
        • Not yet recruiting
        • Sana Klinikum Offenbach
        • Contact:
          • Thomas Wehler, MD
        • Contact:
          • Ioannis Tsoukakis, MD
        • Sub-Investigator:
          • Ingo Stehle, MD
      • Offenburg, Germany, 77654
        • Recruiting
        • Ortenau Klinikum, Offenburg-Gengenbach
        • Contact:
          • Carsten Schwänen, MD
        • Contact:
          • Irmgard Dresel, MD
        • Sub-Investigator:
          • Jochen Rentschler, MD
      • Oldenburg, Germany, 26121
        • Recruiting
        • Pius Hospital Oldenburg
        • Contact:
          • Imme Conradi, MD
        • Contact:
          • Frank Griesinger, MD
      • Oldenburg, Germany, 26133
        • Recruiting
        • Klinikum Oldenburg gGmbH
        • Contact:
          • Jochen Casper, MD
        • Contact:
          • Andrea Renzelmann, MD
      • Passau, Germany, 94032
        • Recruiting
        • Klinikum Passau
        • Contact:
          • Thomas Südhoff, MD
        • Contact:
          • Thorsten Nitsch, MD
      • Regensburg, Germany, 93053
        • Recruiting
        • Universitätsklinikum Regensburg
        • Contact:
          • Daniel Heudobler, MD
        • Contact:
          • Hendrik Poeck, MD
      • Saarlouis, Germany, 66740
        • Recruiting
        • Marienhaus Klinikum St. Elisabeth Saarlouis
        • Contact:
          • Alessandro Falgiatore, MD
        • Contact:
          • Katharina Gräber, MD
      • Sande, Germany, 26453
        • Recruiting
        • Sande, Nordwest-Krankenhaus Sanderbusch
        • Contact:
          • Detlev Kohl, MD
        • Contact:
          • Jan-Eike Behrends, MD
      • Stuttgart, Germany, 70174
        • Recruiting
        • Klinikum Stuttgart
        • Contact:
          • Jan Schleicher, MD
        • Contact:
          • Lisa Pospiech, MD
        • Sub-Investigator:
          • Markus Knott, MD
      • Stuttgart, Germany, 70176
        • Recruiting
        • Stuttgart, Diakonie-Klinikum
        • Contact:
          • Jochen Greiner, MD
        • Contact:
          • Susanne Jung
      • Traunstein, Germany, 83278
        • Recruiting
        • Klinikum Traunstein
        • Contact:
          • Elisabeth Dietl, MD
        • Contact:
          • Thomas Kubin, MD
      • Trier, Germany, 54290
        • Recruiting
        • Mutterhaus der Borromäerinnen
        • Contact:
          • Rolf Mahlberg, MD
        • Contact:
          • Stefan Heidel, MD
      • Trier, Germany, 54292
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier
        • Contact:
          • Heinz Kirchen, MD
        • Contact:
          • Monika Lankeshofer-Loch, MD
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen
        • Contact:
          • Claudia Lengerke, MD
        • Contact:
          • Wichard Vogel, MD
        • Sub-Investigator:
          • Wolfgang Bethge, MD
      • Ulm, Germany, 89081
        • Recruiting
        • Universitatsklinikum Ulm
        • Contact:
          • Verena Gaidzik, MD
        • Contact:
          • Hartmut Döhner, MD
      • Villingen-Schwenningen, Germany, 78052
        • Recruiting
        • Schwarzwald-Baar Klinikum Villingen- Schwenningen GmbH
        • Contact:
          • Paul Graf La Rosée, MD
        • Contact:
          • Martin Henkes, MD
      • Wuppertal, Germany, 42283
        • Recruiting
        • Helios Klinikum Wuppertal
        • Contact:
          • Silke Schostock, MD
        • Contact:
          • Blasius Liss, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Patient Inclusion Criteria:

  1. Patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria [Appendix B]), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification
  2. Age ≥ 18 years, no upper age limit
  3. Patient considered eligible for intensive chemotherapy
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening
  5. Genetic assessment in AMLSG central laboratory
  6. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × ULN or creatinine clearance >40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR)

  7. Adequate hepatic function as evidenced by:

    • Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) unless considered due to Gilbert's disease, or leukemic involvement following approval by the Coordinating Investigator or Co-Coordinating Investigator
    • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following approval by the Coordinating Investigator or Co-Coordinating Investigator
  8. No prior chemotherapy for acute leukemia except hydroxyurea for up to 7 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell [WBC] counts >30x109/l); prior treatment of myelo-dysplastic syndrome with hypomethylating agents is allowed
  9. Non-pregnant and non-nursing women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within a sensitivity of at least 25 mIU/mL within 72 hours prior to randomization ("Women of childbearing potential" is defined as a sexually active mature woman who has not undergone a hysterectomy or bilateral oophorectomy or who has had menses at any time in the preceding 24 consecutive months)
  10. Female patients of childbearing potential must agree to avoid getting pregnant while on therapy and for 27 weeks after the last dose of study drug
  11. Women of childbearing potential must either commit to continued abstinence from heterosexual intercourse or apply one highly effective method of birth control (such as IUD, bilateral tubal ligation, or partner's vasectomy) in combination with one acceptable method of birth control at the same time (such as hormonal contraception or the male partner has to use a latex condom coated with spermicide lubricant or combined with spermicide gel or foam) while on therapy and for 27 weeks after the last dose of study drug. Hormonal contraception is only a highly effective method of birth control in case of combined (estrogen and progestogen containing) associated with inhibition of ovulation or progestogen-only hormonal contraception associated with inhibition of ovulation is used
  12. Men must use a latex condom coated with a spermicide lubricant or combined with spermicide gel or foam during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 6 months after the last dose of study drug). In addition, their female partners of childbearing potential have to use a highly effective method of birth control
  13. Able to understand and willing to sign an informed consent form (ICF)

Patient Exclusion Criteria:

  1. AML with favorable-risk genetics according to 2017 ELN criteria [Appendix B]:

    • AML with t(8;21)(q22;q22.1), RUNX1-RUNX1T1
    • AML with inv(16)(p13.1q22)/t(16;16)(p13.1;q22), CBFB-MYH11
    • AML with mutated NPM1 without FLT3-ITD or with FLT3-ITDlow
    • AML with biallelic CEBPA mutation
  2. AML with FLT3 mutation as assessed by DNA fragment analysis PCR for FLT3-ITD and FLT3-TKD mutation. Positivity is defined as a FLT3-ITD or FLT3-TKD / FLT3-WT ratio of ≥ 0.05 (5%).
  3. Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12); PML-RARA; or one of the other pathognomonic variant chromosomal translocations/ fusion genes
  4. AML with BCR-ABL1
  5. Prior treatment of myelodysplastic syndrome (MDS) with intensive chemotherapy or bone marrow transplant with a curative intent
  6. Significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; myocardial infarction, unstable angina and/or stroke; severe cardiac arrhythmias, or left ventricular ejection fraction (LVEF) <50% by ultrasound obtained within 28 days prior to the start of study treatment
  7. Severe obstructive or restrictive ventilation disorder
  8. Uncontrolled infection
  9. Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required, if there is a clinical suspicion of CNS involvement by leukemia during screening
  10. Evidence of active hepatitis B or C infection or known Human Immunodeficiency Virus (HIV) infection

  11. Patients with a "currently active" second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at < 30% risk of relapse within one year. However, subjects with the following history/concurrent conditions are allowed:

    • Basal or squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histologic finding of prostate cancer
  12. Severe neurological or psychiatric disorder interfering with ability to give an informed consent
  13. No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
  14. No consent for biobanking of patient's biological specimens
  15. Current participation in any other interventional clinical study within 30 days before the first administration of the investigational product or at any time during the study
  16. Patients with prior cumulative anthracycline exposure of daunorubicin (or equivalent) can be included but the maximum of daunorubicin (or equivalent) dose of 550 mg/m2 must not be exceeded. Anthracycline-based therapy should be avoided until exposure to the previous cardiotoxic agents is negligible. If this is not possible, the patient's cardiac function should be carefully monitored and an absolute cumulative dose of 400 mg/m² in adults can be exceeded only with great caution. In patients who received radiation therapy to the mediastinum the maximum of daunorubicin (or equivalent) dose of 400 mg/m2 must not be exceeded.
  17. Known or suspected hypersensitivity to cytarabine, daunorubicin or liposomal products and/or any excipients
  18. History of Wilson's disease or other copper-metabolism disorder
  19. Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: Subjects, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard arm
Drug: Cytarabine

Induction therapy: 200 mg/m2 i.v. (continuously) d1-7

Consolidation therapy:

  • Patients age 18-60 years

    o Intermediate-dose cytarabine 1500 mg/m2 i.v. q12h (3 hrs) d1-3

  • Patients age >60 years o Intermediate-dose cytarabine 1000 mg/m2 i.v. q12h (3 hrs) d1-3
Drug: Daunorubicin
Induction therapy: 60 mg/m2 i.v. (1 hr) d1-3
Experimental: Investigational arm
Drug: CPX-351

Induction 1:

o CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine [100 U/m²] i.v. (90 min) d1,3,5

Induction 2:

o CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine [100 U/m²] i.v. (90 min) d1,3

Consolidation therapy:

o CPX-351 29 mg/m2 daunorubicin / 65 mg/m2 cytarabine [65 U/m²] i.v. (90 min) d1,3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS) in the restricted set of de novo patients
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS) in the extended set of patients
Time Frame: 2 years
2 years
Event-free survival (EFS) with CRi considered as response to induction therapy in both, the restricted set of de novo patients and the extended set of patients
Time Frame: 2 years
2 years
Event-free survival (EFS) with CRi considered as failure of induction therapy in the restricted set of de novo patients
Time Frame: 2 years
2 years
Rate of objective response in the restricted set of de novo patients
Time Frame: 2 months
complete remission [CR], CR with incomplete hematologic recovery [CRi], CRi without measurable residual disease [CRiMRD-], CR without measurable residual disease [CRMRD-])
2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFS with CRi considered as failure of induction therapy in the extended set of patients
Time Frame: 2 years
Exploratory endpoint
2 years
Response rates (CR/CRi/CRMRD-/CRiMRD-) in the extended set of patients
Time Frame: 2 years
Exploratory endpoint
2 years
Relapse-free survival (RFS) in patients who achieved CR/CRi during induction chemotherapy
Time Frame: 2 years
Exploratory endpoint
2 years
Relapse-free survival (RFS) in patients who achieved CR during induction chemotherapy
Time Frame: 2 years
Exploratory endpoint
2 years
Cumulative incidence of relapse (CIR) in patients who achieved CR/CRi during induction chemotherapy
Time Frame: 2 years
Exploratory endpoint
2 years
Cumulative incidence of relapse (CIR) in patients who achieved CR during induction chemotherapy
Time Frame: 2 years
Exploratory endpoint
2 years
Cumulative incidence of death (CID) in patients who achieved CR/CRi during induction chemotherapy
Time Frame: 2 years
Exploratory endpoint
2 years
Cumulative incidence of death (CID) in patients who achieved CR during induction chemotherapy
Time Frame: 2 years
Exploratory endpoint
2 years
EFS with allogeneic HCT considered as competing event
Time Frame: 2 years
Exploratory endpoint
2 years
RFS with allogeneic HCT considered as competing event
Time Frame: 2 years
Exploratory endpoint
2 years
CIR with allogeneic HCT considered as competing event
Time Frame: 2 years
Exploratory endpoint
2 years
CID with allogeneic HCT considered as competing event
Time Frame: 2 years
Exploratory endpoint
2 years
OS with allogeneic HCT considered as competing event
Time Frame: 2 years
Exploratory endpoint
2 years
QoL NCI PRO-CTCAE (National Cancer Institute) Patient Reported Outcomes Common Terminology Criteria for Adverse Events questionnaire)
Time Frame: 2 years
PRO-CTCAE responses are scored from 0 to 4, whereas lower values represent a better outcome. For this trial, the burden of symptoms that will be captured by this questionnaire comprises nausea, diarrhea, rash, and alopecia.
2 years
QoL EORTC QLQ-FA12
Time Frame: 2 years
The EORTC QLQ-FA12 module complements the core EORTC QLQ-C30 questionnaire regarding fatigue. . Each item can be scored in four dimension on a scale from 1 to 4 with higher scores indicating worse symptoms.
2 years
QoL EORTC QLQ-C30 (Core Quality of Life Questionnaire developed by European Organization for Research and Treatment of Cancer)
Time Frame: 2 years
The EORTC QLQ-C30 subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher scores on symptom scales indicating worse symptoms.
2 years
Rate of hospitalization including admissions at intensive care unit (ICU)
Time Frame: 8 months
Exploratory endpoint
8 months
Reasons for hospitalization
Time Frame: 8 months
Exploratory endpoint
8 months
days of hospitalization by treatment setting
Time Frame: 8 months
Exploratory endpoint
8 months
rate of use of anti-infectives and other medications, e.g. against nausea or vomiting
Time Frame: 8 months
Exploratory endpoint
8 months
additional therapies administered
Time Frame: 8 months
Exploratory endpoint
8 months
place of chemotherapy administration (inpatient vs outpatient setting)
Time Frame: 8 months
Exploratory endpoint
8 months
duration of administration
Time Frame: 8 months
Exploratory endpoint
8 months
number of outpatient visits
Time Frame: 8 months
Exploratory endpoint
8 months
Frequency of salvage therapies
Time Frame: 8 months
Exploratory endpoint
8 months
Incidence and intensity of adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version v5.0
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

Jazz Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2019

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMLSG 30-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

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Locations

3
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