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Acute Myeloid Leukemia (AML)Phase 3NCT01237808

Study of Low-Dose Cytarabine and Etoposide With or Without All-Trans Retinoic Acid in Older Patients Not Eligible for Intensive Chemotherapy With Acute Myeloid Leukemia and NPM1 Mutation

A Phase 3 study testing Cytarabine, Etoposide and All-trans retinoic acid (ATRA) in people with Acute Myeloid Leukemia (AML), run by University of Ulm at 33 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 is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation ineligible for intensive chemotherapy. Sample size: 144 patients Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are expected to be included into the trial)… Read more about this study

Who is it for?
Ages 61 years and older
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
Cytarabine, Etoposide and All-trans retinoic acid (ATRA)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
33 sitesGermany
Study dates
Mar 2011to 13 Jul 2018
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 61 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification (including de novo AML, t-AML and s-AML)
  • Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories.
  • Age > 60 years. There is no upper age limit.
  • No prior chemotherapy for leukemia except hydroxyurea to control hyperleukocytosis if needed for up to 10 days during the diagnostic screening phase.
  • Signed written informed consent
  • Men must give their informed consent that they do not father a baby and must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy. (while on therapy and for 3 month after the last dose of chemotherapy)
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  • WHO performance status ≤ 3
  • Patients not eligible for intensive chemotherapy according to at least one of the following criteria
  • HCT-CI Score >2
  • Patient's decision
  • age ≥ 75 years

Who cannot join

  • The presence of any of the following will exclude a patient from study enrollment:
  • All other AML subtypes, in particular those AML with other recurrent genetic changes (according to WHO 2008):
  • AML with t(8;21)(q22;q22); RUNX1-RUNX1T1
  • AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
  • AML with t(15;17)(q22;q12); PML-RARA (or other translocations involving RARA)
  • AML with t(9;11)(p22;q23); MLLT3-MLL (or other translocations involving MLL)
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  • AML with t(6;9)(p23;q34); DEK-NUP214
  • AML with inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1
  • No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician and all other treating physicians about study participation
  • Bleeding disorder independent of leukemia
  • Uncontrolled infection
  • Known positive for HIV, HBV or HCV
  • Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or ALP >2.5x upper normal serum level, not attributable to AML; heart failure NYHA III/IV; severe obstructive or restrictive ventilation disorder)
  • Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Germany33 sites

  • Ubbo-Emmius Klinik Aurich

    Aurich, 26603

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

  • University Hospital of Bonn

    Bonn, 53111

  • Städtisches Klinikum Braunschweig

    Braunschweig, 38114

  • Klinikum Bremen-Mitte gGmbH

    Bremen, 28177

  • Kliniken Essen Süd, Evangelischs Krankenhaus

    Essen, 45239

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Medizinische Universitätsklinik

    Freiburg im Breisgau, 79106

  • Medizinisches Versorgungszentrum Osthessen GmbH

    Fulda, 36043

  • Universitätsklinikum Gießen

    Giessen, 35392

  • Wilhelm- Anton- Hospital gGmbH

    Goch, 47574

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • University Hospital of Hamburg Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Medical Department III, Hospital of Hannover-Siloah

    Hanover, 30449

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • Department of Internal Medicine I, University Hospital of Saarland

    Homburg, 66421

  • Staedtisches Klinikum Karlsruhe

    Karlsruhe, 76133

  • Department of Interial Medicine /Hematology and Oncology, Caritas Hospital Lebach

    Lebach, 66822

  • Klinikum der Johannes Gutenberg Universität Mainz

    Mainz, 55131

  • Klinikum rechts der Isar der TU Muenchen

    München, 81675

  • Stauferklinikum Schwäbisch Gmünd

    Mutlangen, 73557

  • Pius Hospital Oldenburg

    Oldenburg, 26133

  • Krankenhaus der Barmherzigen Brueder

    Regensburg, 93049

  • Caritas-Klinik St. Theresia

    Saarbrücken, 66113

  • Clinikal Cetner of Stuttgart, Center of Oncology

    Stuttgart, 70174

  • Diakonie-Klinikum Stuttgart

    Stuttgart, 70176

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • University hospital of Ulm

    Ulm, 89081

  • Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen

    Villingen-Schwenningen, 78050

  • Helios Klinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

About this study

This is a randomized, Phase-III, two-arm, open-label, multi-center study in adult patients with AML and NPM1 mutation ineligible for intensive chemotherapy.

Sample size: 144 patients

Investigator's sites: 50-55 sites in Germany and Austria (2-10 patients per trial site are expected to be included into the trial)

Estimated treatment duration of an individual patient: 8 months (Follow-Up period per patient will last additional 2 years)

Being tested
Cytarabine, Etoposide, All-trans retinoic acid (ATRA)
Keywords
AML, NPM1 Mutation, elderly patients (>60 years), unfit for intensive chemotherapy
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.

  • CytarabineDrug

    in all treatment cycles: Cytarabine 20 mg/day, s.c., bid, days 1-7; (total dose 280 mg).

  • EtoposideDrug

    first treatment cycle Etoposide 50 mg/m²/day, continuously i.v., days 1-3; (total dose 150 mg/m2) treatment cycles 2 to 6 Etoposide 100 mg/day, p.o. or i.v. (over 1 hour), days 1-3; (total dose 300 mg).

  • All-trans retinoic acid (ATRA)Drug

    in all treatment cycles: ATRA 45 mg/m²/day p.o., days 8-10, ATRA 15 mg/m²/day p.o., days 11-28, with or shortly after meals distributed on 3 doses per day.

Study groups in NCT01237808
Study groupRoleWhat they receive
Standard armActive comparator6 cycles of chemotherapy (low-dose cytarabine and etoposide) without ATRA
Receives: Drug: Cytarabine; Drug: Etoposide
Investigational armExperimental6 cycles of chemotherapy (low-dose cytarabine and etoposide) with ATRA (All-trans-Retinoic acid)
Receives: Drug: Cytarabine; Drug: Etoposide; Drug: All-trans retinoic acid (ATRA)

What is being measured

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

  1. overall survival

    Measured: 2 years and 8 months

Secondary outcomes (11)

  1. Rate of Complete remission

    Measured: 8 months

  2. cumulative incidence of relapse

    Measured: 2 years and 8 months

  3. cumulative incidence of death in complete remission

    Measured: 2 years and 8 months

  4. event-free survival

    Measured: 2 years and 8 months

  5. Rate of early deaths (ED)/hypoplastic deaths (HD)

    Measured: 8 months

  6. Type, frequency, severity, timing and relatedness of adverse events (AEs) and laboratory abnormalities observed during different treatment cycles

    adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.0

    Measured: 8 months

  7. Incidence of infection after each treatment cycle

    Measured: 8 months

  8. Duration of neutropenia after each treatment cycle

    Measured: 8 months

  9. Duration of thrombocytopenia after each treatment cycle

    Measured: 8 months

  10. Duration of hospitalization after each treatment cycle

    Measured: 8 months

  11. Quality of life

    assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics according to Messerer et al.33

    Measured: 2 years and 8 months

Timeline

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

  1. First posted10 Nov 2010 (estimated)
  2. Study startMar 2011
  3. Primary completion13 Jul 2018
  4. Study completion13 Jul 2018

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
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01237808
Sponsor's protocol ID
AMLSG 15-10
Status last verified
Jul 2018
First submitted
9 Nov 2010
Last updated
1 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cytarabine, Etoposide and All-trans retinoic acid (ATRA) in people with Acute Myeloid Leukemia (AML), run by University of Ulm at 33 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 11 inclusion and 15 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 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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?

overall survival (time frame: 2 years and 8 months). 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 NCT01237808.

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 1 Aug 2018.

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