Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008836

Trial Description

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Title

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

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Trial Acronym

ETAL3-ASAP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00008836
  •   2015/06/25
  •   2015/05/28
  •   yes
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Secondary IDs

  •   2014-003124-44 
  •   NCT02461537  (ClinicalTrials.gov)
  •   DKMS-14-01  (DKMS Deutsche Knochenmarkspenderdatei Gemeinnützige Gesellschaft mbH)
  •   2014-003124-44 
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Health Condition or Problem studied

  •   Acute Myeloid Leukemia
  •   C92.0 -  Acute myeloblastic leukaemia [AML]
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Interventions/Observational Groups

  •   Drug: Cytarabine
  •   Drug: Mitoxantrone
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Disease-free survival; time frame: on day 56 after allogeneic SCT

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Secondary Outcome

- Overall survival; time frame: 4 weeks, 8 weeks, and 24 weeks from randomization
- Rate of allogeneic transplantation; time frame: 4 weeks, 8 weeks, and 16 weeks from randomization
- Incidence of CR; time frame: at 4 weeks, 8 weeks, and 24 weeks from randomization

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Countries of Recruitment

  • [---]*
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Locations of Recruitment

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Recruitment

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  •   2015/06/30
  •   308
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- 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.

- HLA-identical sibling. or HLA-compatible (8/8) unrelated donor with completed
confirmatory typing. or One potential HLA compatible (8/8) donor plus at least two
back-up donors, who are at least 9/10 matches with >90% probability for each of
them.

- For the relapse stratum:

- First AML relapse, defined as ≥5% bone marrow blasts and / or extramedullary AML
manifestation.

- For the poor-responders stratum:

- If patient ≤60 years old: High risk AML according to ELN-criteria and ≥5% bone
marrow blasts after the first cycle of induction therapy.

- If patient >60 years old: Non-favourable risk AML according to ELN-criteria and
≥5% bone marrow blasts after the first cycle of induction therapy.

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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 ≥1g/ m2.

- Patient has received more than 80% of the tolerable cumulative anthracycline dose
(see chapter 7.2. for definitions and worksheet for calculation).

- Severe organ dysfunction, .

- Uncontrolled infection at the time of enrollment.

- History of allogeneic transplantation.

- Manifestation of AML in the central nervous system.

- Pregnant or breast-feeding women.

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Addresses

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    • DKMS Deutsche Knochenmarkspenderdatei Gemeinnützige Gesellschaft mbH
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    • Universtitätsklinikum Dresden
    • Johannes Schetelig 
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    • Raquel Palencia 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   5
  •   2015/06/21
* This entry means the parameter is not applicable or has not been set.