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Acute Myeloid LeukemiaPhase 3ETAL3-ASAPNCT02461537

Impact of Remission Induction Chemotherapy Prior to Allogeneic SCT in Relapsed and Poor-response Patients With AML

A Phase 3 study testing HAM and LDAC and/or Mitoxantrone in people with Acute Myeloid Leukemia, run by DKMS gemeinnützige GmbH at 18 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial compares outcome of two treatment strategies for patients with high-risk AML who failed to achieve or maintain a complete remission with standard therapy. Patients will be randomized between two strategies. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
HAM and LDAC and/or Mitoxantrone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
281 participants
Where
18 sitesGermany
Study dates
17 Sep 2015to 12 Jan 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Germany18 sites

  • Universitätsklinikum Aachen, AÖR

    Aachen, Nordrhein-Westphalen, 52074

  • Klinikum Augsburg

    Augsburg, Bavaria, 86156

  • Helios Klinikum Berlin Buch

    Berlin, 13125

  • University Hospital

    Dresden, Saxony, 01307

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Universitätsklinikum Essen (AöR)

    Essen, Nordrhein-Westphalen, 45147

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60595

  • Universitätsklinikum Halle (Saale)

    Halle, Saxony-Anhalt, 06120

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitätsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

  • Klinikum Nürnberg Nord

    Nuremberg, Bavaria, 90419

  • Elblandkliniken Stiftung & Co. KG

    Riesa, Saxony, 01589

  • Robert-Bosch-Krankenhaus

    Stuttgart, Baden-Wurttemberg, 70376

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Rems-Murr-Kliniken gGmbH

    Winnenden, Baden-Wurttemberg, 71364

Other trials in Germany

About this study

Official title: Evaluation of the Impact of Remission Induction Chemotherapy Prior to Allogeneic Stem Cell Transplantation in Relapsed and Poor-response Patients With AML

This trial compares outcome of two treatment strategies for patients with high-risk AML who failed to achieve or maintain a complete remission with standard therapy. Patients will be randomized between two strategies. The standard strategy is aimed at achieving a complete remission by aggressive salvage chemotherapy using high dose cytarabine and mitoxantrone, . The alternative is a less toxic disease-control strategy of disease monitoring and, if necessary, low-dose cytarabine or mitoxantrone prior to allogeneic transplantation, which should be performed as soon as possible.

Read the detailed description

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.

Being tested
HAM, LDAC and/or Mitoxantrone
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAMDrug

    High-dose cytarabine 1 - 3 g/m2 (days 1-3)/Mitoxantrone 20 mg/m2 (days3-5)

  • LDAC and/or MitoxantroneDrug

    Low-dose cytarabine 20 mg/m2 (days 1-10) and/ or mitoxantrone 10mg/m2 (max 3 doses)

Study groups in NCT02461537
Study groupRoleWhat they receive
RIST(remission induction)Active comparatorhigh-dose cytarabine 3 g/m2 (days 1-3)/mitoxantrone 10mg/m2 (days 3-5)
Receives: Drug: HAM
DISC (disease control)Experimentallow-dose cytarabine 20 mg/ m2 and /or mitoxantrone 10mg/m2
Receives: Drug: LDAC and/or Mitoxantrone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

    Disease-free survival

    Measured: on day 56 after allogeneic SCT

Secondary outcomes (3)

  1. Overall survival

    Overall survival

    Measured: 4 weeks, 8 weeks, and 24 weeks from randomization

  2. Rate of allogeneic transplantation

    Rate of allogeneic transplantation

    Measured: 4 weeks, 8 weeks, and 16 weeks from randomization

  3. Incidence of CR

    Incidence of CR

    Measured: at 4 weeks, 8 weeks, and 24 weeks from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2015 (estimated)
  2. Study start17 Sep 2015
  3. Primary completion5 Apr 2022
  4. Study completion12 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02461537
Sponsor's protocol ID
DKMS-14-01
Other IDs
2014-003124-44, 2014
Acronym
ETAL3-ASAP
Status last verified
Aug 2022
First submitted
28 May 2015
Last updated
19 Jan 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Stelljes M, Middeke JM, Bug G, Wagner-Drouet EM, Muller LP, Schmid C, Krause SW, Bethge W, Jost E, Platzbecker U, Klein SA, Niederland J, Kaufmann M, Schafer-Eckart K, Baldauf H, Stolzel F, Trost S, Rollig C, von Bonin M, Egger-Heidrich K, Kunadt D, Steffen B, Hauptrock B, Schliemann C, Sockel K, Lang F, Kriege O, Schaffrath J, Reicherts C, Berdel WE, Serve H, Ehninger G, Schmidt AH, Mikesch JH, Bornhauser M, Schetelig J. Disease risk but not remission status determines transplant outcomes in AML: long-term outcomes of the ASAP trial. Blood. 2025 Nov 6;146(19):2293-2305. doi: 10.1182/blood.2025028730.

    PubMed 40737595

  • Stelljes M, Middeke JM, Bug G, Wagner-Drouet EM, Muller LP, Schmid C, Krause SW, Bethge W, Jost E, Platzbecker U, Klein SA, Schubert J, Niederland J, Kaufmann M, Schafer-Eckart K, Schaich M, Baldauf H, Stolzel F, Petzold C, Rollig C, Alakel N, Steffen B, Hauptrock B, Schliemann C, Sockel K, Lang F, Kriege O, Schaffrath J, Reicherts C, Berdel WE, Serve H, Ehninger G, Schmidt AH, Bornhauser M, Mikesch JH, Schetelig J; Study Alliance Leukemia and the German Cooperative Transplant Study Group. Remission induction versus immediate allogeneic haematopoietic stem cell transplantation for patients with relapsed or poor responsive acute myeloid leukaemia (ASAP): a randomised, open-label, phase 3, non-inferiority trial. Lancet Haematol. 2024 May;11(5):e324-e335. doi: 10.1016/S2352-3026(24)00065-6. Epub 2024 Apr 4.

    PubMed 38583455

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HAM and LDAC and/or Mitoxantrone in people with Acute Myeloid Leukemia, run by DKMS gemeinnützige GmbH at 18 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: on day 56 after allogeneic SCT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02461537, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.

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