Acute Myeloid LeukemiaPhase 2DELTANCT02446145
A Randomized Placebo-controlled Phase 2 Study of Decitabine With or Without Eltrombopag in AML Patients
A Phase 2 study testing Eltrombopag in people with Acute Myeloid Leukemia, run by Technische Universität Dresden at 15 sites in Germany.
Trial summary
Acute myeloid leukemia (AML) is a disease with a poor prognosis including a 5-year overall survival (OS) of app. 20% for the entire population. In particular, the outcome of elderly patients with AML is dismal and the majority of patients die within the first year after diagnosis. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Eltrombopag
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 15 sitesGermany
- Study dates
- May 2015to 25 Jan 2023
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Newly diagnosed AML (including therapy-related or with antecedent MDS) other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate / biopsy or peripheral blood must contain ≥20% blasts in AML defined by cytogenetic aberrations according to WHO the proportion of blasts may be <20%
- Age ≥ 65 years
- Eastern Cooperative Oncology Group performance status (ECOG) 0-3
- patients not eligible for intensive induction therapy (according to investigator's decision)
- planned therapy with DAC/AZA
- platelet count <75 Gpt/L taken within 4 weeks prior to randomization
Show all 10Show fewer
- adequate liver function as assessed by the following laboratory requirements during screening (within 4 weeks prior to study inclusion):
- Total bilirubin ≤ 3 times the upper limit of normal (except for Gilbert's Syndrome)
- Alanine transaminase (ALAT) and Aspartate transaminase (ASAT) ≤ 3 times upper limit of normal
- signed Informed Consent
Who cannot join
- acute promyelocytic leukemia (APL)
- history of higher-risk MDS or AML treatment with thrombopoietin receptor (TPO-R) agonists, hypomethylating agents or intensive chemotherapy
- substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding to first dose of study mediation
- uncontrolled active infection
- New York Heart Association (NYHA) stage ≥ 2 due to heart insufficiency
Show all 9Show fewer
- positive Human Immunodeficiency Virus (HIV) or Hepatitis B / C serology
- patients unable to swallow medication
- known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to EPAG or DAC or excipients that contraindicates their participation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
Uniklinik RWTH Aachen
Aachen
Charite Campus Benjamin Franklin
Berlin
Klinikum Chemnitz GmbH
Chemnitz
Universitätsklinikum Dresden
Dresden
Marienhospital Düsseldorf GmbH
Düsseldorf
Universitätsklinikum Essen
Essen
Universitätsklinikum Halle (Saale)
Halle
St. Marien-Hospital Hamm
Hamm
Klinikum rechts der Isar der TU München
München
Klinikum Nürnberg-Nord
Nuremberg
Medizinisches Versorgungszentrum für Blut- und Krebserkrankungen
Potsdam
Wissenschaftskontor Nord GmbH & Co KG
Rostock
Diakonie-Klinikum Schwäbisch Hall gGmbH
Schwäbisch Hall
Rems-Murr-Klinikum Winnenden
Winnenden
Universitätsklinikum Würzburg
Würzburg
About this study
Official title: A Randomized Placebo-controlled Phase 2 Study of Decitabine With or Without Eltrombopag in AML Patients ≥65 Years of Age Not Eligible for Intensive Chemotherapy
Acute myeloid leukemia (AML) is a disease with a poor prognosis including a 5-year overall survival (OS) of app. 20% for the entire population. In particular, the outcome of elderly patients with AML is dismal and the majority of patients die within the first year after diagnosis. This is also because treatment options for elderly patients with AML significantly differ from patients of younger age. In fact, comorbid conditions are common among the elderly such as heart disease, renal insufficiency and vascular disease thus influencing the ability to withstand intensive therapy. Elderly patients are also more likely than younger patients to develop severe, life threatening infections during the course of treatment. In addition to infectious complications, hemorrhages due to severe thrombocytopenia are responsible for morbidity and mortality in a considerable amount of patients. Compared with younger AML patients, elderly individuals with AML display a higher incidence of poor-prognosis karyotypes, of a preceding myelodysplastic syndrome (MDS), and greater expression of proteins involved in intrinsic resistance to chemotherapeutic agents. As a result conventional anthracycline based chemotherapy is only infrequently used in patients above the age of 65 years. Based on a recent randomized trial (Kantarjian et al. 2012) low-intensity epigenetic therapy with decitabine (DAC) has become the first-line standard of care in most European countries including Germany. Nevertheless, even with this treatment the 1-year OS is approximately 30 % only. Furthermore, severe thrombocytopenia is a main side effect of this therapy and can prevent adequate continuation of treatment being crucially for treatment success. Supportive care with platelet transfusions is effective primarily only over short periods and often requires hospitalization and therefore lowers the quality of life of these patients in their palliative situation. Therefore, patients could benefit from an approach aiming at an increase of platelet counts through combined use of Azacitidine (AZA) or DAC with an oral thrombopoietin receptor agonist like eltrombopag (EPAG). This could allow for a better adherence to DAC/AZA therapy by preventing dose delays due to prolonged thrombocytopenia. Additionally, the potential antileukemic effect of EPAG could also be beneficial for these AML patients.
Read the detailed description
The DELTA-trial is designed as a two-arm, double-blind, multicenter randomized-controlled phase- II study of EPAG or placebo in combination with standard-dose DAC/AZA treatment as concomitant medication in subjects at least 65 years of age with AML not eligible for intensive chemotherapy and planned therapy with Decitabine (DAC)/Azacitidine(AZA). Patients will be randomized 1:1 into the experimental study arm and the control study arm. EPAG 200 mg (100 mg for East Asian patients) once daily has been selected as the starting dose for this study because this regimen has been investigated to be safe and potentially effective in increasing platelet counts in patients with AML. Concomitant medication with DAC/AZA will be according to the european label and the summary of product characteristics. There will be a dose adjustment of EPAG depending on the platelet counts obtained on day 1 of a planned DAC/AZA cycle. EPAG or placebo will be taken for 14 days in each treatment cycle starting on day 12 with a minimum treatment gab of 2 days before and after each DAC/AZA course.
Concomitant medication will be either Decitabine (DAC) 20 mg/m2 body surface i.v. over 30 minutes on days 1-5 of each cycle or Azacitidine (AZA) 75 mg/m2 body surface sc. on days 1-7. One cycle lasts 28 days.
Patients will receive medication as long as they benefit from treatment and in the absence of relevant adverse events indicating a treatment discontinuation; but for a maximum of 12 cycles. During Follow Up (up to 4 years) patient survival and first treatment change will be observed.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Eltrombopag, Placebo
- 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.
EltrombopagDrug
Also called Revolade
Patients will receive EPAG in addition to their background standard treatment with Decitabine/Azacitidine
- concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c.
PlaceboDrug
Patients will receive Placebo in addition to their background standard treatment with Decitabine/Azacitidine
- concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c.
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention arm | Experimental | Eltrombopag daily from day 12 to 25: 200 mg/day p.o. (100 mg for east asian patients) dose modification 100 mg up to 300 mg/d p.o. (50 - 150 mg for east asian patients)
* concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c.
* one cycle lasts 28 days Receives: Drug: Eltrombopag |
| Control intervention arm | Placebo comparator | Placebo daily from day 1: 200 mg/day p.o. (100 mg for east asian patients) dose modification 100 mg up to 300 mg/d p.o. (50 - 150 mg for east asian patients)
* concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c.
* one cycle lasts 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment change-free survival
time from randomization until day one of the new disease modifying treatment or death as the primary endpoint of this study
Measured: up to 4 years
Secondary outcomes (9)
overall survival
Overall survival is defined as months from day 1 of cycle 1 until death and is calculated as (date of death - date of day 1 of cycle 1 + 1) / 30.43
Measured: up to 4 years
relapse free survival
Relapse free survival is defined for patients who achieved CR, CRi, CRc, or CRm.
Measured: up to 4 years
overall response rate
Overall response is defined as achievement of stable disease (SD), partial remission (PR), or complete remission (CR, including CRi, CRc, CRm) at any time during treatment period.
Measured: up to 4 years
number of bone marrow blasts after 5, 9, and 12 months
Bone marrow blasts are determined locally and by central review. The blast count from the central review is preferred in the analysis. In case of missing blast count from central review the locally determined blast count will be used for analysis.
Measured: screening, month 5, 9 and 12
quality of life questionnaire (QLQ-C30)
Quality of life is assessed by the EORTC QLQ-C30 and the SF36 questionnaires. Quality of life will be assessed only in patients with complete baseline assessment. QOL will only be assessed in analysis sets for which information is available for more than 75% of individuals.
Measured: screening, month 1, 3, 6, 9, 12
Short Form questionnaire 36 (SF-36)
Quality of life is assessed by the EORTC QLQ-C30 and the SF36 questionnaires. Quality of life will be assessed only in patients with complete baseline assessment. QOL will only be assessed in analysis sets for which information is available for more than 75% of individuals.
Measured: screening, month 1, 3, 6, 9, 12
median platelet counts
Platelet counts are analysed as recorded in the study database.
Measured: month 1 - 12
number of platelet transfusions
Number of platelet transfusions during cycle 1-4 is defined as the cumulative sum of platelet transfusions documented in cycles 1 to 4.
Measured: month 1 - 4
incidence of serious adverse events (SAE)
incidence of SAE including death, incidence of bleeding events and hospitalization rate and duration
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startMay 2015
- Primary completion26 Dec 2020
- Study completion25 Jan 2023
Why it stopped: Due to COVID-19 pandemia, recruitment was insufficient to reach required sample size in an acceptable time line. Furthermore, new drugs have recently been licensed resulting in alternative treatment regimens with a better prognosis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Uwe Platzbecker, Prof., Principal investigator, Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446145
- Sponsor's protocol ID
- TUD-DELTA1-063
- Other IDs
- 2014-003150-13, 2014
- Acronym
- DELTA
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2015
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Phase 2 Study of Decitabine With or Without Eltrombopag in AML Patients ≥65 Years of Age Not Eligible for Intensive Chemotherapy
- ClinicalTrials.gov ID
- NCT02446145
- Acronym / sponsor ID
- DELTA / TUD-DELTA1-063
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 pandemia, recruitment was insufficient to reach required sample size in an acceptable time line. Furthermore, new drugs have recently been licensed resulting in alternative treatment regimens with a better prognosis.
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2015
- Primary completion
- 26 Dec 2020 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute myeloid leukemia (AML) is a disease with a poor prognosis including a 5-year overall survival (OS) of app. 20% for the entire population. In particular, the outcome of elderly patients with AML is dismal and the majority of patients die within the first year after diagnosis. This is also because treatment options for elderly patients with AML significantly differ from patients of younger age. In fact, comorbid conditions are common among the elderly such as heart disease, renal insufficiency and vascular disease thus influencing the ability to withstand intensive therapy. Elderly patients are also more likely than younger patients to develop severe, life threatening infections during the course of treatment. In addition to infectious complications, hemorrhages due to severe thrombocytopenia are responsible for morbidity and mortality in a considerable amount of patients. Compared with younger AML patients, elderly individuals with AML display a higher incidence of poor-prognosis karyotypes, of a preceding myelodysplastic syndrome (MDS), and greater expression of proteins involved in intrinsic resistance to chemotherapeutic agents. As a result conventional anthracycline based chemotherapy is only infrequently used in patients above the age of 65 years. Based on a recent randomized trial (Kantarjian et al. 2012) low-intensity epigenetic therapy with decitabine (DAC) has become the first-line standard of care in most European countries including Germany. Nevertheless, even with this treatment the 1-year OS is approximately 30 % only. Furthermore, severe thrombocytopenia is a main side effect of this therapy and can prevent adequate continuation of treatment being crucially for treatment success. Supportive care with platelet transfusions is effective primarily only over short periods and often requires hospitalization and therefore lowers the quality of life of these patients in their palliative situation. Therefore, patients could benefit from an approach aiming at an increase of platelet counts through combined use of Azacitidine (AZA) or DAC with an oral thrombopoietin receptor agonist like eltrombopag (EPAG). This could allow for a better adherence to DAC/AZA therapy by preventing dose delays due to prolonged thrombocytopenia. Additionally, the potential antileukemic effect of EPAG could also be beneficial for these AML patients.
Detailed description
The DELTA-trial is designed as a two-arm, double-blind, multicenter randomized-controlled phase- II study of EPAG or placebo in combination with standard-dose DAC/AZA treatment as concomitant medication in subjects at least 65 years of age with AML not eligible for intensive chemotherapy and planned therapy with Decitabine (DAC)/Azacitidine(AZA). Patients will be randomized 1:1 into the experimental study arm and the control study arm. EPAG 200 mg (100 mg for East Asian patients) once daily has been selected as the starting dose for this study because this regimen has been investigated to be safe and potentially effective in increasing platelet counts in patients with AML. Concomitant medication with DAC/AZA will be according to the european label and the summary of product characteristics. There will be a dose adjustment of EPAG depending on the platelet counts obtained on day 1 of a planned DAC/AZA cycle. EPAG or placebo will be taken for 14 days in each treatment cycle starting on day 12 with a minimum treatment gab of 2 days before and after each DAC/AZA course.
Concomitant medication will be either Decitabine (DAC) 20 mg/m2 body surface i.v. over 30 minutes on days 1-5 of each cycle or Azacitidine (AZA) 75 mg/m2 body surface sc. on days 1-7. One cycle lasts 28 days.
Patients will receive medication as long as they benefit from treatment and in the absence of relevant adverse events indicating a treatment discontinuation; but for a maximum of 12 cycles. During Follow Up (up to 4 years) patient survival and first treatment change will be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention arm | Experimental | Drug: EltrombopagEltrombopag daily from day 12 to 25: 200 mg/day p.o. (100 mg for east asian patients) dose modification 100 mg up to 300 mg/d p.o. (50 - 150 mg for east asian patients) * concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c. * one cycle lasts 28 days |
| Control intervention arm | Placebo comparator | Drug: PlaceboPlacebo daily from day 1: 200 mg/day p.o. (100 mg for east asian patients) dose modification 100 mg up to 300 mg/d p.o. (50 - 150 mg for east asian patients) * concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c. * one cycle lasts 28 days |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Newly diagnosed AML (including therapy-related or with antecedent MDS) other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate / biopsy or peripheral blood must contain ≥20% blasts in AML defined by cytogenetic aberrations according to WHO the proportion of blasts may be <20%
- Age ≥ 65 years
- Eastern Cooperative Oncology Group performance status (ECOG) 0-3
- patients not eligible for intensive induction therapy (according to investigator's decision)
- planned therapy with DAC/AZA
Key exclusion criteria (9 listed)
- acute promyelocytic leukemia (APL)
- history of higher-risk MDS or AML treatment with thrombopoietin receptor (TPO-R) agonists, hypomethylating agents or intensive chemotherapy
- substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding to first dose of study mediation
- uncontrolled active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EltrombopagAlso: RevoladePatients will receive EPAG in addition to their background standard treatment with Decitabine/Azacitidine - concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c. | Drug | Experimental intervention arm |
| PlaceboPatients will receive Placebo in addition to their background standard treatment with Decitabine/Azacitidine - concomitant medication: either Decitabine days 1-5 of each cycle: 20 mg/sqm i.v. over 30 minutes or Azacitidine (AZA) days 1-7 of each cycle: 75 mg/sqm s.c. | Drug | Control intervention arm |
Primary outcome
treatment change-free survival
Time frame: up to 4 years
time from randomization until day one of the new disease modifying treatment or death as the primary endpoint of this study
9 secondary outcomes
overall survival
Time frame: up to 4 years
relapse free survival
Time frame: up to 4 years
overall response rate
Time frame: up to 4 years
number of bone marrow blasts after 5, 9, and 12 months
Time frame: screening, month 5, 9 and 12
quality of life questionnaire (QLQ-C30)
Time frame: screening, month 1, 3, 6, 9, 12
Short Form questionnaire 36 (SF-36)
Time frame: screening, month 1, 3, 6, 9, 12
median platelet counts
Time frame: month 1 - 12
number of platelet transfusions
Time frame: month 1 - 4
incidence of serious adverse events (SAE)
Time frame: up to 4 years
Results and safety
The study was stopped early (reason given: Due to COVID-19 pandemia, recruitment was insufficient to reach required sample size in an acceptable time line. Furthermore, new drugs have recently been licensed resulting in alternative treatment regimens with a better prognosis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- homepage of study groupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Platzbecker, Prof. principal investigator
Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eltrombopag in people with Acute Myeloid Leukemia, run by Technische Universität Dresden at 15 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Due to COVID-19 pandemia, recruitment was insufficient to reach required sample size in an acceptable time line. Furthermore, new drugs have recently been licensed resulting in alternative treatment regimens with a better prognosis.). Results are not available in the source record.
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?
treatment change-free survival (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2024.