Impact of Remission Induction Chemotherapy Prior to Allogeneic SCT in Relapsed and Poor-response Patients With AML (ETAL3-ASAP)
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ClinicalTrials.gov Identifier: NCT02461537 |
Recruitment Status :
Recruiting
First Posted : June 3, 2015
Last Update Posted : July 30, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myeloid Leukemia | Drug: HAM Drug: LDAC and/or Mitoxantrone | Phase 3 |
Patients with high-risk acute myeloid leukemia (AML) who relapsed or showed a poor response to induction chemotherapy have a dismal prognosis. For these patients, allogeneic transplantation is the recommended treatment. While allogeneic transplantation may be considered as the ultimate treatment concept, the treatment path to transplantation is not well defined.
The traditional approach to pursue a complete remission by means of aggressive reinduction chemotherapy prior to allogeneic transplantation. This approach is associated with potentially life-threatening toxicities and has limited efficacy. As a result, only some patients will reach allogeneic transplantation in complete remission.
To reduce the number of patients who die or who are ineligible for transplantation due to the toxicity of aggressive induction chemotherapy, other bridging options have been explored. One promising alternative is to abstain from remission induction. Instead, disease control by means of less aggressive chemotherapy or simply monitoring leukemic proliferation can be considered.
This randomized trial will identify if there is non-inferiority of the less toxic approach, compared to the standard approach of remission induction by aggressive chemotherapy prior to allogeneic transplantation.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 308 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of the Impact of Remission Induction Chemotherapy Prior to Allogeneic Stem Cell Transplantation in Relapsed and Poor-response Patients With AML |
Study Start Date : | June 2015 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | May 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: RIST(remission induction)
high-dose cytarabine 3 g/m2 (days 1-3)/mitoxantrone 10mg/m2 (days 3-5)
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Drug: HAM
High-dose cytarabine 1 - 3 g/m2 (days 1-3)/Mitoxantrone 20 mg/m2 (days3-5) |
Experimental: DISC (disease control)
low-dose cytarabine 20 mg/ m2 and /or mitoxantrone 10mg/m2
|
Drug: LDAC and/or Mitoxantrone
Low-dose cytarabine 20 mg/m2 (days 1-10) and/ or mitoxantrone 10mg/m2 (max 3 doses) |
- Disease-free survival [ Time Frame: on day 56 after allogeneic SCT ]Disease-free survival
- Overall survival [ Time Frame: 4 weeks, 8 weeks, and 24 weeks from randomization ]Overall survival
- Rate of allogeneic transplantation [ Time Frame: 4 weeks, 8 weeks, and 16 weeks from randomization ]Rate of allogeneic transplantation
- Incidence of CR [ Time Frame: at 4 weeks, 8 weeks, and 24 weeks from randomization ]Incidence of CR

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Signed written informed consent.
- Male and female patients of 18 to 75 years of age.
- Diagnosis of AML according to WHO criteria.
- Patient is fit for aggressive induction chemotherapy and transplantation by assessment of an experienced hematologist.
- No history of chronic pulmonary disease and absence of dyspnea. Otherwise, documented diffusion lung capacity for carbon monoxide ( DLCO ) ≤ 40 percent ( adjusted for hemoglobin, if available ) and FEV1 / FVC ≥ 50 percent.
- HLA - identical sibling. or
- HLA - compatible unrelated donor ( ≥ 9 /10 antigens matched for HLA - A, - B, - C, -DRB 1, and - DQB 1 ) with completed confirmatory typing or
- Two unrelated donors with > 90 percent probability of a 9 /10 match for HLA - A, - B, - C, - DRB 1, and - DRQB 1, according to Opti Match ® list.
For the relapse stratum
- First AML relapse, defined as ≥ 5 percent bone marrow blasts and / or extramedullary AML manifestation.
For the poor - responders stratum
- AML that evolves from previously documented myelodysplastic syndrome ( MDS ),
and / or
- diagnosis of therapy-related myeloid neoplasm ( t - MN ), and / or
a ) If patient ≤ 60 years old adverse risk AML according to ELN - criteria and ≥ 5 percent bone marrow blasts after the first cycle of induction therapy.
b ) If patient > 60 years old non-favourable risk AML according to ELN - criteria and ≥ 5 percent bone marrow blasts after the first cycle of induction therapy.
Exclusion Criteria
- Acute promyelocytic leukemia ( APL ).
- WBC count of ≥ 50 GPt / L at study inclusion.
- For patients in the poor - responder stratum the first cycle of induction therapy must not contain HDAC, defined as cytarabine at single-doses of > 1 g / m 2.
- Patient has received more than 440 mg / m2 daunorubicin equivalents.
- Severe organ dysfunction, defined as
- Left ventricular ejection fraction < 50 percent.
- Patients who receive supplementary continuous oxygen.
- Serum bilirubin > 1.5 x ULN ( if not considered Gilbert-Syndrome ), ASAT / ALAT > 5 x ULN.
- Estimated GFR < 50 ml / min.
- Treatment with any investigational drug within 10 days before study entry.
- Uncontrolled infection at the time of enrollment.
- History of allogeneic transplantation.
- Manifestation of AML in the central nervous system.
- Pregnant or breast - feeding women.
- Men unable or unwilling to use adequate contraception methods from start of study treatment to minimum of six months after the last dose of chemotherapy.
- Women of childbearing potential except those who fulfill the following criteria: Post-menopausal or post-operative or continuous and correct application of a contraception method with a Pearl Index < 1 percent or sexual abstinence or vasectomy of the sexual partner.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461537
Contact: Raquel Palencia | 49351210798 ext 21 | palencia@dkms.de |
Germany | |
Universitätsmedizin Mannheim III. Medizinische Klinik Hämatologie und Onkologie | Recruiting |
Mannheim, Baden-Württemberg, Germany, 68167 | |
Contact: Michaela Hausmann | |
Principal Investigator: Stefan A. Klein, PD Dr med | |
Robert-Bosch-Krankenhaus | Recruiting |
Stuttgart, Baden-Württemberg, Germany, 70376 | |
Contact: Sandra Heidmann | |
Principal Investigator: Martin Kaufmann, Dr. med. | |
Universitätsklinikum Tübingen Medizinische Klinik und Poliklinik Onkologie, Hämatologie, Rheumatologie und Pulmologie | Recruiting |
Tübingen, Baden-Württemberg, Germany, 72076 | |
Contact: Anja Junker | |
Principal Investigator: Wolfgang Bethge, Prof Dr Med | |
Rems-Murr-Kliniken gGmbH | Recruiting |
Winnenden, Baden-Württemberg, Germany, 71364 | |
Contact: Kathrin Kühn 07195591 ext 36022 kathrin.kuehn@rems-murr-klinikemn.de | |
Principal Investigator: Markus Schaich, Prof.Dr.med. | |
Klinikum Augsburg | Recruiting |
Augsburg, Bavaria, Germany, 86156 | |
Contact: Franziska Knieler | |
Contact: Silvia Söllner | |
Principal Investigator: Christoph Schmid, PD Dr. med. | |
Universitätsklinikum Erlangen | Recruiting |
Erlangen, Bavaria, Germany, 91054 | |
Contact: Ulrike Höfer | |
Contact: Evi Weiß | |
Principal Investigator: Stefan Krause, Prof Dr med | |
Klinikum Nürnberg Nord Medizinische Klinik 5 | Recruiting |
Nürnberg, Bavaria, Germany, 90419 | |
Contact: Karin Westphal | |
Principal Investigator: Kerstin Schäfer-Eckart, Dr Med | |
University Hospital | Recruiting |
Dresden, Free State Of Saxony, Germany, 01307 | |
Contact: Johannes Schetelig, Prof | |
Elblandkliniken Stiftung & Co. KG | Recruiting |
Riesa, Free State Of Saxony, Germany, 01589 | |
Contact: Maria Sonnenfeld 0352575 ext 3075 maria.sonnenfeld@elblandkliniken.de | |
Principal Investigator: Jörg Schubert, Prof.Dr.med. | |
Universitätsklinikum Frankfurt, Med. Klinik II - Hämatologie/Onkologie | Recruiting |
Frankfurt am Main, Hessen, Germany, 60595 | |
Contact: Wagner-Scherneck | |
Principal Investigator: Gesine Bug, PD Dr. med. | |
Universitätsklinikum Aachen, AÖR | Recruiting |
Aachen, Nordrhein-Westphalen, Germany, 52074 | |
Contact: Carmen Döring 024180 ext 35168 cdoering@ukaachen.de | |
Principal Investigator: Edgar Jost, PD Dr. med. | |
Universitätsklinikum Essen (AöR) | Not yet recruiting |
Essen, Nordrhein-Westphalen, Germany, 45147 | |
Contact: Elke Günther 0201723 ext 1861 | |
Principal Investigator: Richard Noppeney, Dr.med. | |
Universitätsklinikum Münster, KMT-Zentrum | Recruiting |
Münster, North Rhine-Westphalia, Germany, 48149 | |
Contact: Vera Gordon | |
Contact: Birgit Mayerhoffer | |
Principal Investigator: Matthias Stelljes, Prof Dr Med | |
III. Medizinische Klinik und Poliklinik Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Recruiting |
Mainz, Rhineland-Palatinate, Germany, 55131 | |
Contact: Christiane Schön | |
Contact: Andrea Schulz | |
Principal Investigator: Eva Wagner, Dr Med | |
Universitätsklinikum Halle (Saale) Klinik für Innere Medizin IV Hämatologie/Onkologie/Hämostaseologie | Recruiting |
Halle, Saxony-Anhalt, Germany, 06120 | |
Contact: Antje Kleinbauer | |
Principal Investigator: Lutz Peter Müller, Dr med habil | |
Helios Klinikum Berlin Buch | Not yet recruiting |
Berlin, Germany, 13125 | |
Contact: Katrin Müller 0309401 ext 52189 | |
Principal Investigator: Herrad Baurmann, Dr.med. |
Study Chair: | Johannes Schetelig | Universtitätsklinikum Dresden |
Responsible Party: | DKMS gemeinnützige GmbH |
ClinicalTrials.gov Identifier: | NCT02461537 |
Other Study ID Numbers: |
DKMS-14-01 2014-003124-44 ( EudraCT Number ) |
First Posted: | June 3, 2015 Key Record Dates |
Last Update Posted: | July 30, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Mitoxantrone Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |